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Software Warning Letters

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 _____ 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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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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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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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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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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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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