Company: Ocuserv Instruments Inc.Product: Ultrasonic Imaging Systems, Autoscan DB 3000, DB 3000C Biometric Rulers and Ophthalmic A-Scan Systems Date: 3/2/04 During an inspection of your firm located in Jamaica, New York, conducted during the dates of January 13, 14 & 23, 2004, our investigator determined that your firm manufactures medical devices under the brand names...Read More

Company: MedRx Inc.Product: “Otowizard” and “Vet Digitizer” Date: 3/1/04 Your firm failed to establish and maintain procedures to adequately control environmental conditions that could reasonably be expected to have an adverse effect on product quality as required by 21 CFR 820.70(c). There was no electro-static discharge (ESD) procedures or other precautions in effect when electronic...Read More

Company: Shanghai Medical Ltd.Product: Active pharmaceutical ingredients Date: 2/10/04 One of the discussion points with management concerned missing data for the analysis of [redacted] and [redacted] by [redacted] There were six entries in the [redacted] logbook that could not be found in the correlating computer files. The investigative team was together during the interaction with...Read More

Company: Imaging Diagnostic Systems Inc.Product: Investigational device Date: 1/28/04 Monitors also failed to observe that the first enrolled patient’s…was assessed with an earlier software version. Because earlier software versions were not equivalent to later versions used in the study, the data should not have been included in the data analysis. Issuer: Center for Devices and...Read More

Company: Respironics California Inc.Product: Espirit mechanical ventilator Date: 1/27/04 The design validation activities conducted for the Esprit ventilator software version 3.2 failed to ensure that the device conforms to the defined user/patient needs and intended uses [21 CFR 820.30]. Specifically: There was no documented evidence that any integration and throughput testing of the device was...Read More

Company: Rocky Mountain Lions Eye BankProduct: Human corneas, sclera and whole eye globes Date: 1/26/04 Paragraph 12 of the Biohazardous Waste Disposal procedure includes the provision that the Quality Assurance (QA) staff will review and verify the documentation of destroyed tissue on the Destruction Log is consistent with the record entry in the chart and...Read More

Company: James Howe M.D. – University of Vermont College of MedicineProduct: Investigational device Date: 1/16/04 The x-rays and radiology report for patient [redacted] 24-month visit in 2002 were not included in the subject’s file. The patient’s Radiographic Evaluation form you signed on September 27, 2002, shortly after [redacted] 24-month visit was scheduled to take place,...Read More

Company: IND Diagnostic Inc.Product: Medical device Date: 12/23/03 Failure to establish and maintain procedures 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). Issuer: Center for...Read More

Company: Eldon Biologicals A/S.Product: Medical device Date: 12/23/03 Microsoft 2000 Excel spreadsheet software used manufacturing has not been validated for the purpose of generating a worksheet for formulation of reagents. No documentation was found to establish or verify corrections made to the program. Failure to validate computer software for its intended use according to an...Read More

Company: Medron Inc.Product: Various catheters Date: 12/3/03 We are in receipt of your correspondence dated June 6, 2003 in response to the FD-483 issued at the conclusion of the inspection. Your response is inadequate in that all numbered items listed above were not addressed. However, we acknowledge that you have implemented some corrective action with...Read More

Company: Central Texas Regional Blood and Tissue CenterProduct: Blood products Date: 11/7/03 Specifically, one donor tested Nucleic Acid Test (NAT) HIV positive on a unit donated 4/4/2002. The donor donated a Whole Blood unit on 4/16/2002. The testing laboratory requested the Fresh Frozen Plasma (FFP) to be tested from the 4/16/2002 donation and all tests...Read More

Company: Tri-State Analytical Laboratory LLCProduct: Analyzed drug products Date: 10/22/03 Inadequate Standard Operating Procedures that are not always available, lack appropriate details, or contain contradictory information. For example, the written procedure for method validation lacks detailed instructions and acceptance criteria for each test and conflicts with the protocol. Additionally, some software application and microbiology lab...Read More

Company: Medi-Stat Inc.Product: Pulse oximeter sensors Date: 10/17/03 The Device Master Record you submitted is inadequate. A Device Master Record is specific for each device and must include or refer to the location of the following information: a.) device specifications, including appropriate drawings, composition, formulation, component specifications and software specifications; b.) production process specifications including...Read More

Company: Nutra Med Inc.Product: Over-the-counter and prescription drug products Date: 10/2/03 Failure to maintain records of the inspections of automatic, mechanical or electronic equipment, including computers or related systems. [211.68(a)]. For example, equipment qualification was not adequate for the following drug manufacturing equipment: Double Cone Blender (_____ kg.), Fitzpatrick Fitzmill Comminuting Machine, Coating Pans, Kent...Read More

Company: Consolidated Machine Corp.Product: Steam sterilizers Date: 9/24/03 Our inspection confirmed that in 1994 your firm introduced the Mark V microprocessor that is marketed as an attachment to all of your approximately fourteen steam sterilizers. This microprocessor is software driven and controls the time and temperature of the sterilization cycles. This microprocessor addition constitutes a...Read More

Company: Con-Cise Lens Co.Product: Rigid gas permeable contact lenses Date: 9/19/03 Failure to perform and document validation of computer software that is used as part of production [21 CFR 820.70(i)]. Specifically, the software used to control the DAC DLL Series 3…has not been validated. We note that seven items on the Form FDA 483 issued...Read More

Company: Laborde Diagnostics at South CollegeProduct: Mammography facility Date: 9/12/03 The specific deficiency noted above appeared on the MQSA Post Inspection Report, which was given to your facility by the state inspector along with instructions on how to respond to this finding. Your facility responded to this same noncompliance issue in a letter dated September...Read More

Company: Medicapharma.comProduct: “Roaccutane Isotretinoin 10 mg tablet” Date: 9/9/03 Accutane (isotretinoin) is a systemically administered retinoid approved in 1982 to treat severe recalcitrant nodular acne. Isotretinoin carries significant potential risks, including that it may cause severe birth defects. The approved Accutane labeling states in part. “Accutane must not be used by females who are pregnant…must...Read More

Company: Today’s BusinessProduct:”Isotrex Isotretinoina Gel 0.05%” Date: 9/9/03 “Accutane must not be used by females who are pregnant…must be prescribed under the System to Manage Accutane Related Teratogenicity (S.M.A.R.T.), a yellow Accutane Qualification Sticker must be on each prescription,” (meaning special training has been given to the prescribing licensed practitioner and the patient) “and no...Read More

Company: Medicine-MexicoProduct: “Isotrex Isotretinoina Gel 0.05%” Date: 9/9/03 “Accutane must not be used by females who are pregnant…must be prescribed under the System to Manage Accutane Related Teratogenicity (S.M.A.R.T.), a yellow Accutane Qualification Sticker must be on each prescription,” (meaning special training has been given to the prescribing licensed practitioner and the patient) “and no...Read More

Company: Edrugnet.comProduct:”Roaccutane Isotretinoin 10 mg capsules” Date: 9/9/03 Accutane (isotretinoin) is a systemically administered retinoid approved in 1982 to treat severe recalcitrant nodular acne. Isotretinoin carries significant potential risks, including that it may cause severe birth defects. The approved Accutane labeling states in part, “Accutane must not be used by females who are pregnant…must be...Read More

Company: Medsmex.comProduct: “Isotrex Isotretinoina Gel 0.05% Date: 9/9/03 Accutane (isotretinoin) is a systemically administered retinoid approved in 1982 to treat severe recalcitrant nodular acne. Isotretinoin carries significant potential risks, including that it may cause severe birth defects. The approved Accutane labeling states in part, “Accutane must not be used by females who are pregnant…must be...Read More

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Company: Invacare Corp. Product: Power wheelchairs and scooters Date: 8/26/03 With regard to the 80 amp fuse and …wire assembly, the May 15, 2003 and May 20, 2003 responses indicate that an 80 amp current through this assembly is only sustained for a short period of time. Invacare states that a continuous 80 amp current...Read More

Company: Boston Scientific Corp.Product: Investigational medical device Date: 8/22/03 For example, the …and the …do not describe whether the monitor should verify all case histories and related documentation or only select a representative sample during the visit. If a sample is to be selected, the procedures do not state the size and composition of this...Read More

Company:Astro Instrumentation LLCProduct: Chemistry analyzers and renal dialysis filter reprocessing system Date: 8/21/03 Your August 4, 2003 response stated that you routinely use electronic copies of the manufacturing procedures and that a lack of a computer at this work station prompted the use of a paper copy. The response states that you have placed a...Read More

Company: Bioflex Inc..Product: Electrical stimulation devices Date: 8/18/03 Failure to establish procedures to ensure that equipment is routinely calibrated, checked and maintained. [21 CFR 820.72(a)] For example, the…meter used to test the electrodes on the BioShort electronic stimulation garments has not been calibrated and there is no calibration program for this meter. Failure to establish...Read More

Company: Mercy Medical Center Product: Blood bank facility Date: 07/25/03 Failure to maintain an adequate number of trained and experienced personnel for the processing, compatibility testing, storage, and distribution of blood or blood components. For example, employee…who was responsible for completing validation of the …software, was also responsible for Quality Assurance, supervisory and administrative duties,...Read More

Company: South Texas Blood and Tissue CenterProduct: Blood facility Date: 7/17/03 Your facility failed to check input to and output from its computer and related systems for accuracy [21 CFR 211.68(b)]. For example, Your facility’s _____ computer system and _____ lacked controls or procedures to prevent improper sample analysis or mix-ups. As explained above (1.a),...Read More

Company: MagneVu Product: Portable magnetic resonance imaging (MRI) system Date: 07/11/03 Software validation activities for computers or automated data processing systems used as part of production have not been performed or documented [21 CFR 820.70(i)]. Specifically, the Eng MagMRI software used for engineering and servicing of the MagneVu 1000 MRI System has not been validated....Read More

Company: ConMed Corp. Product: Hyfrecator 2000 and other electrosurgical devices and accessories Date: 05/08/2003 Failure to validate computer software for its intended use according to an established protocol prior to approval and issuance, and document the results of these validation activities, as required by 21 CFR 820.70(i). For example, a software program used to run...Read More

Company: Antelope Valley Healthcare District Product: Blood and blood components Date: 05/01/2003 Specifically, the procedure “Donor Registration and Medical Interview,” which includes instructions for entering deferral information into the computer system based on disqualifying information provided during the donor screening process, does not provide details concerning the documentation of information (such as exposure dates) so...Read More

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Company: Advanced Radiation Measurements Inc.Product: Radiation beam scanners Date: 3/25/03 Your firm failed to validate processes whose results cannot be fully verified by subsequent inspection and test according to established procedures as required by 21 CFR 820.75. Structural testing conducted as part of your firm’s software validation, and software validation of the Scan Test used...Read More

Company: Innovative Products Unlimited Inc.Product: Medical Device products including gurneys Date: 3/4/03 No procedures to control labeling activities, as required by 21 CFR 820.120. For example, while you maintain master labels for your gurney models, these master labels lack signatures and dates to document that they have been reviewed and approved, and there are no...Read More

Company: MAK-SYSTEM S.A. International GroupProduct: Progesa Soundex file module Date: 02/06/2003 All users are not notified of existing problems or fixes until a user encounters the problem. Software corrections are only provided to the user that discovered and reported the problem and not to other users of the computer system/software. For example There were no...Read More

Company: Merits Health Products Co. Ltd. Product: Powered wheelchairs, electric scooters and oxygen concentrators Date: 02/04/2003 Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i). For example,...Read More

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....Read More

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...Read More

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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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More