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warningletter

Software Warning Letters

Company: Lexicor Medical Technology Inc.Product: DataLex Web portal Date: 1/16/03 We are writing to you because on July 3 through 17, 2002, an investigator from the Food and Drug Administration (FDA) collected information that revealed a serious regulatory problem involving the product known as “DataLex” web portal which is made and marketed by your firm....
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Company: Siemens Medical Solutions USA Inc.Product: Diagnostic x-ray system Date: 1/14/03 You are requested to report the results of your investigation and follow-up action to this office within thirty (30) working days of receipt of this letter. Your response should include the date that the corrective action was completed and copies of service records and/or...
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Company: Eastern Medical Equipment Distributors Inc.Product: Oxygen USP and Oxygen Analyzer Date: 12/17/02 Failure to routinely calibrate mechanical and electronic equipment used in the transfilling of Oxygen USP or keep records of calibration according to a written program designed to assure proper performance as required by 21 CFR 211.68. For example, there was no documentation...
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Company: Eastern Medical Equipment Distributors Inc.Product: Oxygen USP and Oxygen Analyzer Date: 12/17/2002 Failure to routinely calibrate mechanical and electronic equipment used in the transfilling of Oxygen USP or keep records of calibration according to a written program designed to assure proper performance as required by 21 CFR 211.68. For example, there was no documentation...
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Company: UPC Medical Supplies Inc.Product: Sacred Crane TDP Lamp, QL-Wide Band Spectrum Apparatus and other products Date: 11/01/2002 Claims for the Stimplus II Acupoint Locator & Stimulation device include that it “locate[s] acupoints and then stimulate away the pain electronically at the touch of a button without needles. Acupoints are detected with sound and light…Stimplus...
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Company: UPC Medical Supplies Inc…Product: Sacred Crane TDP Lamp, QL-Wide Band Spectrum Apparatus and other products Date: 11/1/2002 Claims for the Stimplus II Acupoint Locator & Stimulation device include that it “locate[s] acupoints and then stimulate away the pain electronically at the touch of a button without needles. Acupoints are detected with sound and light…Stimplus...
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Company: Heimann Systems CorporationProduct: Cabinet x-ray system Date: 10/30/2002 21 CFR 1020.40(c)(10) requires that x-ray systems designed for security screening of carried possessions in public facilities shall be provided with means to insure operator presence at the control area in a position which permits surveillance of the ports during generation of x-radiation. We observed that...
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Company: Unico Holdings Inc.Product: Over-the-counter drug products Date: 10/18/02 In answer to observations made about not performing specific gravity testing as required by the covering monograph, your response states your belief that under certain circumstances not every analytical procedure listed in an article’s monograph needs to be performed, but offers no documentation or historical data...
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Company: Abbott Laboratories Inc.Product: Drug products Date: 10/15/2002 Failure to assure that automated equipment will perform a function satisfactorily during the manufacturing process for your drug products [21 CFR 211.68]. For example, The _____ process control computer monitoring system that is used to monitor various production and processing operations (e.g., operation conditions, equipment and component...
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Company:Serv-A-Pure Co.Product: Water purification systems for hemodialysis Date: 10/10/2002 Design Control and Design Inputs and Outputs. Your response to FDA-483 observation # 4 addresses the specific observation that the records were not signed and dated. We are concerned that the records referred to in this observation are maintained on a computer system, and your response...
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Company: Med-Mart Pulmonary ServicesProduct: Inhalation solutions Date: 9/30/02 Failure to perform routine calibration and to assure proper performance of all automatic, mechanical, and electronic equipment used in the manufacture, processing, packing, and holding of a drug product [21 CFR 211.68]. For example, your filtration unit, _____ small batch filler unit, industrial scale, _____ Pump, and...
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Recipient: Ronald G. Crystal M.D.Product: Investigational biologic products Date: 9/23/02 Subject _____ was enrolled in the study without Computerized Tomography (CT) documentation of the number of _____ present at the time of enrollment. Section 3.2 of the protocol requires that the subject have two or more _____ detected by CT scan. Issuer: Center for Biologics...
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Company: University of Massachusetts Memorial Medical Center.Product: Blood products Date: 9/12/02 In no more than fifteen (15) working days of receiving this letter, please notify this office in writing of the specific steps you have taken to correct these violations and to prevent them from recurring. Your response should also indicate the status of the...
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Company: Unit Dose Packaging Inc.Product: Drug products Date: 8/29/02 Failure to establish a written procedure to calibrate, inspect, and check automated, mechanical, or electronic equipment used to manufacture drug products to assure proper performance. [21 CFR 211.68 (a)]. Specifically, there is no data to demonstrate that production equipment (two mixers, one filler, a water system)...
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Company: University Hospitals of ClevelandProduct: Blood products Date: 8/19/02 With respect to your response to FDA-483 item #2, you stated that you will institute a computer change. We expect that changes to the computer system should be validated. Please provide documentation of the validation for this new change. Additionally, please explain what actions and/or retraining...
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Company: Fresenius Medical CareDate: 7/25/02 Product: Naturalyte Acid Concentrate Your firm failed to validate the new salt delivery system for process deviation 2002-005 dated February 1, 2002 for Naturalyte Acid Concentrate lot 2B0017 as required by 21 CFR 820.75. Furthermore, the new computer software included with the new salt delivery system is not validated for...
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Company: Abbott LaboratoriesDate: 7/19/02 Product: Drug products including Biaxin and Meridia FDA compared the MedWatch forms in your computer to your paper files, and this comparison revealed inaccurate data in serious and unexpected adverse drug experience reports submitted to FDA. These inaccurate reports are a violation of 21 CFR 314.80(c)(1)(i). FDA District: Chicago District Office
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483Company: American Red Cross City and Sate: Baltimore, MD FDA District: Baltimore, MD Dates of Inspection: 4/22-6/21/02 4. Failure of the quality control unit to determine root cause and prevent recurrence of significant deviations related to BSD 73.200M, “Shipping” version 1.7 January 2001. Between October 22, 2001 and April 23, 2002, the Chesapeake Region recorded...
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Company: St. Gobain Ceramiques Avancees DesmarquestProduct: Medical Devices Date: 4/26/02 You need to property validate the … furnace process. Please supply a complete proposed validation protocol for the … furnace. This protocol should specifically address if any aspect of this furnace is computer controlled and how the software will be validated. Enclosed are copies of...
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Company: A-VOX Systems Inc.Date: 4/18/2002 Product: Various oximeter models used for whole blood measurements and disposable cuvettes Failure to maintain procedures to ensure all purchased or otherwise received products and services conform to specified requirements [21 CFR 820.50; see also 820.80]. For example, your firm failed to ensure that the supplier of the main computer...
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Company: American Dental Technologies Inc.Date: 4/18/02 Product: Dental device systems, including PulseMaster 600-IQ and DioLase ST Dental Laser System, PowerPAC High Speed Curing Light System, KCP 5 and 1000 Air Abrasive Kinetic Cavity Preparation System and Ultracam Intraoral Camera System Failure to maintain adequate device master records [21 CFR 820.181] [FDA- 483 Item 5]. For...
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Company: Ochsner Clinical FoundationDate: 03/05/2002 Product: Investigational device The manual does not adequately describe how the CIC support staff prepares and maintains records of all IRB activities, including meeting minutes, records and reports associated with investigations, and archiving. The manual does not describe how data and information are gathered, stored, and analyzed to prevent research...
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Company: Sysmex CorpDate: 01/22/2002 Product name: Clinical laboratory diagnostic devices, including hematology, reticulocyte, urinalysis and coagulation analyzers Failure to establish and maintain documented procedures to control and verify the design of the device in order to ensure that specified design requirements are met, as specified in 21 CFR 820(a)(1). For example, there were no procedures...
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Company: Pharmaceutical Distribution SystemsDate: 01/03/2002 Product: Drug products Failure to exercise appropriate controls over and to routinely calibrate, inspect, or check automatic, mechanical, or electronic equipment used in the manufacturing, processing, and packaging of a drug product according to a written program designed to assure proper performance (21 CFR 211.68) in that, the installation qualification...
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Company: Natural Technology Inc.Date: 12/14/01 Product: Drug products Failure to maintain records of calibration checks and inspections of automatic, mechanical, or electronic equipment [21 CFR 211.68(a)]. For example, incubator and refrigerator thermometers associated with equipment that stores microbiological media have not been calibrated. FDA District: Dallas District Office
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Company: Medical Device Services Inc.Date: 12/13/2001 Product Name: Single use medical devices, such as general surgery, orthopedic, laparoscopic and cardiovascular instruments, including biopsy forceps, needles, burrs, drill bits, saw blades, trocars, retractors, blood pressure cuffs, catheters and guidewires Failure to validate computer software for its intended use according to an established protocol prior to approval...
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Company: Cardinal Enterprises Inc. Date: 12/07/2001 Product: Drug products Master production and control records are not prepared, dated, and signed by one person with a full handwritten signature and independently checked, dated and signed by a second person. Master production records are generated from a computer as electronic records without any apparent controls to assure...
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Company: Bunnell Inc.Date: 10/29/01 Product: High frequency jet ventilators and accessories for neonatal use Failure to validate processes that cannot by fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a). For example the compliant handling software program, ultrasonic sealing procedure, leak testing procedure, and injection molding procedure have not been validated....
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Company: Sorenson Development IncDate: 10/17/01 Product: Infusion pumps and other medical devices Failure to validate processes with a high degree of assurance where the results cannot be fully verified by subsequent inspection and testing, and have those processes approved and documented according to established procedures, as required by 21 CFR 820.75(a). Specifically, revalidation of the...
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Company: Grand RapidsDate: 10/1/01 Product: Thumper cardiopulmonary resuscitator Your response to FDA-483 point #6 regarding 21 CFR Part 11 – Electronic Records is not adequate as explained in more detail below. 21 CFR Part 11 During the FDA inspection it was discovered that electronic records are used to establish the firm’s Complaint Files, 21 CFR...
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Company: B. Braun Medical Inc.Date: 9/17/01 Product: Disposable IV sets Failure to validate computer software used to (1) control the Eto sterilization process, for example, _____ cycles, and (2) control the _____ _____) employed in the manufacture of disposable IV sets, to ensure the software will perform for its intended use. 21 CFR 820.70(i). FDA...
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Company: Cleveland Medical Devices Inc.Date: 9/17/01 Product: Wireless medical telemetry monitoring systems No documented corrective and preventative action for software bugs found during retrospective validation. Validation testing revealed several responses that were unexpected and may potentially adversely effect the performance of the Model 15 The above stated inspection revealed that your devices are adulterated within...
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Company: Total Medical Information Management Systems Inc.Date: 9/7/01 Product: Picture archiving and communications systems software During an inspection of your establishment located in Longwood, Florida on August 6-7, 2001, FDA Investigator Ronald T. Weber determined that your establishment is a manufacturer and distributor of picture archiving and communication systems software, which is a medical device...
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Company: Lee Memorial Health SystemDate: 8/27/01 Product: Blood bank The inspection revealed failure of your blood bank to adequately determine the suitability of persons to serve as whole blood donors. One donor (unit _____) tested repeatedly reactive for HIV 1-2 in screening tests performed on March 21, 2001 and was never placed in deferral. Donor...
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Company: Southeastern Home Oxygen Service Inc.Date: 8/7/01 Product: Medical Oxygen You failed to assure the adequacy of your firm’s current computer distribution tracking system. Review of 2 lots selected at random for comparison of production records with computerized tracking information revealed inconsistencies in the number of oxygen cylinders filled with those distributed. FDA District: Atlanta...
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Company: American Blood Resources AssociationDate: 7/31/01 Product: Blood Bank Deferral Software During an inspection of your facility located in Annapolis, Maryland, on June 18 through 22, 2001, Food and Drug Administration (FDA) investigators determined that you manufacture and distribute, Blood Bank Deferral Software. This software is a device within the meaning of section 201(h) of...
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Company: Kaken Pharmaceutical Co Ltd.Date: 7/27/01 Product: Drug Products Written procedures for production, process control, and laboratory operations were not always followed to assure that APIs have the appropriate quality and purity. The inspection reported numerous instances regarding the following operations which present a general practice of not following written procedures: -Stability testing -Storage of...
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Company: SeQual Technologies Inc.Date: 7/18/01 Product: Oxygen Failure to ensure that a process whose results cannot be fully verified by subsequent inspection and testing, has been validated and approved according to established procedures [21 CFR 820.75(a)]. Specifically, your firm has no documented evidence that provides a high degree of assurance that the manufacturing specifications and...
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Company: Paul E. Garland M.D.Date: 7/11/01 Product: Excimer Laser Medical devices used by doctors in their course of their practice to treat patients are “marketed” and “held for sale” within the meaning of the Federal Food, Drug and Cosmetic Act (the Act). An excimer laser is a class III device under section 513(f) of the...
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Company: Cardinal Health Inc.Date: 7/10/01 Product: Drug Products Failure to have an adequate validation procedure for computerized spreadsheets used for in-process and finished product analytical calculations. The current validation procedure uses only the values that result in within specification findings, aberrant high findings, and aberrant low findings [21 CFR 211.165(e)]. For example, SOP 644.00, QA/QC...
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Company: EP MedSystemsDate: 7/10/01 Product: Cardiac Catheters Your firm failed to validate several computer databases that are used for quality functions including your Access database, your _____ software, and your MS Excel spreadsheet program as required by 21 CFR 820.70(i). FDA District: New Jersey
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Company: SciOptic InternationalDate: 7/9/01 SciOptic has contended that the _____ could be considered as a “custom device” within the meaning of 21 CFR 812.3(b). FDA has previously informed you that the _____ is not a custom device as it does not meet the necessary criteria found in section 520(b) of the Act, or in 21...
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Company: Aventis Bio-ServicesDate: 6/29/01 Product: Blood Products There are no written procedures and controls in place to assure that the manual permanently deferred donor files are checked when determining the suitability of new donors. Not all permanently deferred donors are included in your _____ computer system. In order to verify that a new donor is...
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Company: Transplantation Research FoundationDate: 6/25/01 Product Name: Dura mater allografts Failure to establish and maintain procedures to control product that does not conform to specified requirements [21 CFR 820.90]. For example, the computer disposition records did not clearly document the destruction of unsuitable dura mater, and there are no disposition procedures addressing the segregation and...
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Company: Marshall Medical Center North Date: 6/20/01 Product name: Mammography facility Note: The wording of this noncompliance was changed in the software to incorporate several other similar noncompliance issues. The finding is specific to corrective action for a failing image score not being documented FDA District: New Orleans District
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483Company: Schering-Plough Prodcuts, LLC City and Sate: Manati, Puerto Rico 00674-0486 FDA District: San Juan, Puerto Rico Dates of Inspection: 5/1/01-6/13/01 You failed to have adequate security controls for your HPLC system, once accessed by one employee is left opened and available for other personnel to gain access to the original employee’s analytical test reports....
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483Company: Schering-Plough Prodcuts, LLC City and State: Las Pierdas, PR FDA District: San Juan, Puerto Rico Dates of Inspection: 5/1-6/5-2001 You have not developed validation/qualification master plans encompassing process, cleaning computer and analytical method validation as directed by the Corporate Quality Assurance Guideline titled Master Plans for Validation/ Qualification issued 10/12/1999. You failed to have...
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Company: Stough Enterprises Date: 4/18/01 Product: Blood & Plasma Product Category: Biologics/Blood Failure to appropriately determine the suitability of donors prior to the collection and distribution of the blood product because on January 30, 2001, a donor screener was observed reading the questions too quickly for the donor to respond prior to the screener entering...
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Company: AvidcareWL Date: 4/17/01 Product: In home Asthma Monitoring System …”Under a United States Federal law, the Federal Food, Drug and Cosmetic Act (the Act), these products are considered to be medical devices because they are used to diagnose or treat a medical condition or to affect the structure or function of the body. Home...
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Company: Cardiomedics Inc.Date: 4/13/01 Product: Counter pulsation devices No procedures for the development of software used to control devices. The software used for the operation of the CardiAssist CounterPulsation system was not properly validated. Problems with this software have been identified and corrective measures have been undertaken to replace this software version. Electro Static Discharge...
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Company: GE Medical Systems Inc. SADate: 4/10/01 Product: Full Field Digital Mammography Device Failure to establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing...
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Company: Neuro Control Corp. Date: 4/9/01 Product: NeuroControl Freehand System Also, at the time of the meeting your firm was using a procedure entitled, “Return Inspection Procedure for the Freehand Backup Implantable Components”. As we stated in our meeting with your firm, this procedure appears to involve electronic record. The recent FDA inspection revealed that...
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Company: Zeus Scientific Inc.Date: 3/27/01 Product: IVD test kits In addition to the above,your firm failed to validate the electronic documentation system used to record corrective action requests (CARs) prior to implementation. The electronic record requires electronic signature,for which there is no timestamp on the record. Also, you failed to certify to the FDA that...
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/Docs/Lilly483Response031801.pdf
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483Company: Eli Lilly & Company City and Sate: Indianapolis, IN FDA District: Detroit, MI Dates of Inspection: 1/29-2/9, 21, 22, 23/01 18. SOP #001-001757 “Process Control System Security” is used as a global document to describe the guidelines for maintaining the security of the process control systems and related documents for Parentaeral Products Operations. However,...
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Company: Aventis Behring L.L.C.Date: 1/22/01 Product: Biological products Product category: Human Drugs Failure to exercise appropriate controls over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel [21 CFR 211.68(b)] in that changes were not implemented to restrict access and entry...
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Company: Pharmacia Corp. Product name: Sterile drug products Product category: Human drugs Date: 1/11/01 The xxxx operation uses both the yyyy System and zzzz network computer software programs for materials and data management functions. The —- performs functions typical of a laboratory information management system. The quality control unit uses this program for disposition of...
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Company: Pharmacia Corp. Product name: Sterile drug products Product category: Human drugs Date: 1/11/01 The xxxx operation uses both the _____ System and _____ network computer software programs for materials and data management functions. The _____ performs functions typical of a laboratory information management system. The quality control unit uses this program for disposition of...
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Societa Italiana Mediciniali Scandicci 12/6/00 APIs …The computer systems used to control and/or monitor production, reconcile raw materials, assign batch numbers, and control solvents, have not been validated. The validation of the computer system used to control the … process is incomplete…. We have also reviewed your November 3, 2000 written response to the FDA-483…...
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SOL Pharmaceuticals – Active pharmaceutical ingredients – Human Drugs For example, values in at least two … areas were altered. Altered values were written under computer generated values on the … and used in the potency calculations. Review of the electronic data confirmed the incorrect values, which were part of your submission to DMF Your...
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The _____ systems calibrated by an outside contractor did not include verification of the precision (% RSD) of the autoinjector at more than one injection volume, the flow rate below 1 ml/min, or the wavelength accuracy for the wavelength regions used for testing of _____. In addition, the _____ software programs had not been verified...
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“Your firm failed to adequately validate software integral to the IVD, IVD wireless and … devices as required by 21 CFR 820.75. For example, structural testing of the software is not completed or documented, there are no software validation protocols available, and the compilers were not validated (FDA 483, Item #5).” SoftwareCPR keywords: Product software,...
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Oak Rubber Inc. 9/14/00 Examination gloves A failure to validate the manufacturing process and the computer system used to maintain the product inventory and shipping information. FDA New Orleans District SoftwareCPR Keywords: production software
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Crystal Medical Technology 9/14/00 Dental Implant Devices The inspection revealed deviations from Part 820 including failure to have a manufacturing validation study protocol and to validate software manufacturing equipment and the autoclave sterilization cycle, failure to conduct internal audits, incomplete Device Master Records and Standard Operating Procedures, no Design Plan, no change control procedures and...
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Failure to maintain accurate, complete, and current records of device accountability [21 CFR 812.140(b)(2)]. There is no documentation of the number of_____ and _____ manufactured and distributed, the number of copies of the controlling software made, or the disposition of each copy of the software. There are no records showing to which sites the device...
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Company: Baxter Healthcare Corp. Date: 8/11/00 Product: Drug Products Failure to conducted and/or document input/output checks of the _____ computer system. [21CFR211.68] In addition, we further request details regarding steps your firm is taking to bring your electronic cGMP records into conformance with the requirements of 21 CFR Part 11; Electronic Records; Electronic Signatures. Part...
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21 CFR 820.184 (d), requires the Device History Record (DHR) to contain or refer to the location of records that demonstrate that the device is manufactured in accordance with the Device Master Record (DMR). Our investigator noted that the wavelength spectrum printout at 200 mWatts (mW) of laser power was not kept nor filed in...
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We are writing to you because we have obtained information that has revealed a serious regulatory problem involving a product known as “Dermal Tone,” which is marketed by your firm. The Dermal Tone is promoted and sold on the Internet at www.dermaltone.corn. See enclosed website material dated 6/29/00. This website material states that “The Dermal...
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Failure to have appropriate controls over computer or related systems to assure that changes in records are instituted only by authorized personnel, as required by 21 CFR 211.68(b). For example, see FDA-483 observation 12.
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Failure to establish and maintain procedures for validating the device design to include validation and to perform design validation under defined operating conditions on initial production units, lots, or batches, or their equivalents; and failure to ensure that devices conform to defined user needs and intended uses and to include testing of production units under...
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Failure to develop, conduct, control and monitor production processes; failure to review the associated data and documentation for finished devices prior to release; failure to validate processes adequately; failure to establish and maintain procedures for implementing corrective and preventive action; failure to validate computer software adequately; and five other violations. Failure to validate computer software...
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The computer software your firm uses to determine metals analysis is deficient. It has no security measures to prevent unauthorized access of the software, no audit trails, and data can be copied or changed at will, with no documentation of the copying or changes. Your procedures do not require the documentation of calculation or entry...
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6. Failure to designate an individual to review for adequacy and approve prior to issuance all documents established to meet the requirements of Part 820 as required by 21 CFR 820.40(a). For example: a) There is no requirement for documenting the signature of the individual approving the document. In your firm’s letter of April 6,...
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You failed to evaluate suppliers of components and other materials used to assemble the WatchChildTM device. You had not documented your decisions to use the approved vendors on the approved vendor list. While you have a written procedure for supplier certification and recertification, it was not being followed. The type and extent of control to...
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Failure to validate computer software for its intended use according to an established protocol, as required by 21 CFR 820.70( i). For example, the firm did not validate software for electronic records and electronic signatures. Your written responses dated Feb. 25, April 3, and April 13,2000, stated that you would formalize the policy regarding electronic...
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.Failure to maintain device master records (DMR’s) for each type of device including or referring to the location of device specifications, including appropriate drawings, composition, formulation, component specifications, and software specifications, as required by 21 CFR 820.181(a) . For example:.
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You have also failed to establish written procedures for all operations being performed by your blood bank. No written procedures are established for registering donors electronically, registering donors manually on your mobile unit, maintaining your donor base and searching for duplicate and/or unsuitable donors on a set schedule, review of donor suitability records to assure...
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Limberg Eye Center 4/17/00 Failure to maintain complete and accurate records [21 CFR 812.140(a)]. Information on some of the case report forms (CRFS) did not agree with the computerized subject records and vice versa for those records that were originally captured on the CRF and then transcribed to the computerized source records. Moreover, UCVA readings...
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Harper Hospital Blood Bank 4/13/00 Failure to perform/maintain computer validation [21 CFR 211.68] in that: there was no validation protocol to show how the system was tested and what were the expected outcomes; there was no documentation to identify the operator performing each significant step, date completed, whether expected outcomes were met, and management review;...
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Euclid Systems – contacts 4/12/00 The devices are adulterated within the meaning of Section 501(h) of the Act, in that the methods “used in, or the facilities or controls used in the manufacture, processing, packaging, storage, or distribution of Orthokeratology (itaflurofocon B), toric, and aspheric contact lenses, are not in conformance with the Quality System...
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Exmoor advised in its response that professional auditor training will be provided and that subsequent in-house training will be conducted and documented for key staff with auditing responsibilities. Furthermore, training needs will not only be assessed during appraisal and counseling sessions, but also during Quality Management Review Meetings, external audits, internal audits and corrective actions....
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Electric Mobility – Scooters and power chairs 4/3/00 “…Your firm did not validate your _____ computer system which is used for quality control data, order entry and inventory functions. [21 CFR 820.70(i)” SoftwareCPR keywords: production software validation
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St. Joseph’s Hospital and Medical Center Blood Bank 3/16/00″…6. Inadequate computer security in that employees have access to functions they are not qualified to perform. For example, Technical Assistants (TA) have access to the Blood Order Processing function, Blood Label Check function and Blood Product Testing function, although they are not qualified to perform the...
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Failure to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results, as required by 21 CFR 820.72(a). For example, the _____ used to ____ in _____, has not been validated, to assure it is...
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Thoratec Laboratories 3/10/00″..4. .The implementation of corrective and preventative action (CAPA) procedures at your firm is incomplete in that your procedures do not include reference to the Access electronic database. This database captures information from sources such as complaints and nonconformance reports for use during management reviews. In addition, battery assembly defects, such as loose...
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Individual Monitoring Systems -Electroencephalogry 2/11/00 “…Failure to validate computer software for its intended use. For example, your firm has not validated the software used to perform sensitivity calibration of the ActiTrac device. “ SoftwareCPR keywords: production software validation.
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http://www.fda.gov/foi/warning_letters/m3401n.pdf
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Compnay: SOL PharmaceuticalsProduct: Active pharmaceutical ingredients Poduct Category: Human Drugs Date: 1/21/200 In addition, our investigative team found it impossible to trace computer generated …because they were not date stamped.
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Diasorin, Saluggia Italy 23-Dec-99 production/QC software validation for reagents”8. Failure to ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use [21 CFR 820.70(g)] in that the Gamma Counter Data Transfer Validation, dated March 31. 1999. did not...
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7. Failure to maintain complete and adequate written SOPS that reflect current bloodbank operations as requiredby21 CFR 606.100(b) and 606.60. For example, with respect to the computer system in use, there were no SOPS available for security procedures for unauthorized access, review of the system and correction of errors, and control of changes in hardware...
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3d) Standard operating procedure Routine Release of Crossmatched Blood and Blood Products has not been updated to include computter operations utilizing xxx Blood Bank and Blood Donor Computer System versionyyyy. Specifically, the procedure does not include what type of second verification of information entered into the computer should be performed when blood products are released...
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Failure to validate the EtO sterilization process for ATI plasma exchange tubing setsand off-the-shelf software for compiling clinical trial data. Also there are no procedures established and maintained for monitoring and controlling the process parameters for the ATI plasma exchange tubing sets to ensure that specified requirements are met as required by 21 CFR 820.75....
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Mountain View Blood Bank 10/5/99 The _____ Procedure, Revision Date 10-26-94, required donors who test repeatedly reactive for HTLV- 1/2, HIV, HBsAg and HCV to be permanent y deferred and the donors notified. Employees lacked adequate training because they were not following this procedure [21 CFR 606.20(b)]. The donor deferral files were not adequate to...
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Failure to review and evaluate all complaints and maintain a record of the reason no investigation was made and the name of the individual responsible for the decision not to investigate; failure to maintain records that demonstrate that each batch, lot, or unit of device meets in-process or finished device specifications; failure to validate and...
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6. Failure of the DMR (device master record) to include device specifications including appropriate drawings, composition, formulation, component specifications and software specifications, as required by 21 CFR 820.181(a). For example:
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CRS-USA LASIK 8/18/99 Clinical Trial Software Validation There was no verification that the data submitted by the clinical investigators matched source data at the site. The only data verification was performed by the computer data service, xxxx and involved scrutinizing the data for such errors as out-of-range data, field entry omissions, exam dates out-of-range, and...
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South Florida Blood Bank 8/12/99 The inspection revealed that complete and accurate donor deferral records are not being maintained. A deferred donor that tested repeatedly reactive HBsAg on February 12, 1998 (Unit #2251435) was improperly re-entered for donation on August 12, 1998 without a neutralization test being performed. This donor should have remained in deferral....
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Vitalograph Ltd., 6-Aug-99, Spirometers and peak flow meters 4. Failure to establish and maintain process control procedures for the monitoring and control of process parameters during production, as required by 21 CFR 820.70(a) and (b). For example, the firm failed to measure the temperature of the wave-soldering machine at the start of every PCB Kit...
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