Recipient: Spinetronics, LLC .Product: Antalgic-Trak Date: 7/25/2011 Violations include, but are not limited to, the following: 1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a)(1). For example: You do not have design control procedures....Read More

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Recipient: Verichem Laboratories Inc.Product: clinical chemistry reference materials for in-vitro diagnostic (IVD) use Date: 12/16/10 1. Failure to validate the design under defined operating conditions and by using initial production units, lots, batches, or their equivalents, as required by 21 CFR 820.30(g). b) Your firm failed to perform design validation for the data analysis software...Read More

Recipient:Cincinnati Sub-Zero Products, Inc. Product:Blanketrol II, Blanketrol III, Electri-Cool II, Micro-Temp LT, Hemotherm, Norm-O-Temp, Extra Corporeal Membrane Oxygenation Blood Temperature Control System, and Warm Air Hyperthermia System Date:12/13/2010 Failure to establish and maintain adequate procedures for validating the device design, including software, to ensure that devices conform to user needs and intended uses and include...Read More

Recipient: Perma Pure LLC.Product: moisture exchange gas dryers Date: 9/21/10 The inspection revealed that your devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C. 351(h)) in that the methods used in, or the facilities or controls used for their manufacture, packing, storage, or installation are not in conformity with the...Read More

Recipient: OptoviIe, Inc.. Product: RTVue Optical Coherence Tomography (OCT) with the Normative Database (NDB) Date: 6/11/10 Our inspection revealed your device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C....Read More

Recipient: 3CPM, Inc.Product: electrogastrogram (EGG) devices Date: 325/10 6. Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example: b. When requested, no evidence that the changes made to the finished device or...Read More

Recipient: Brymill CorporationProduct: liquid nitrogen cryosurgical devices Date: 2/18/09 The inspection revealed that these devices are adulterated within the meaning of section 501 (h) of the Act (21 U.S.C. 351 (h)), in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage or installation are not in conformity with...Read More

Recipient: Amsino MedicalProduct: sodium chloride and heparin catheter lock-flush solutions Date: 4/3/09 This inspection revealed these devices are adulterated within the meaning of Section 501(h) of the Act (21 U.S.C., Section 351(h)), because the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation do not conform with the...Read More

Recipient: Mainline Technology, Inc Product: Mainline Confirms Strep A, Mainline Confirms Strep A Dots, FYI hCG Urine One-step Pregnancy Test, Mainline Confirms hCG One-step Pregnancy Test, Mainline Confirms III hCG One-Strep Pregnancy Test, and Mainline hCG Accuracy Check pos+ and neg- controls. Date: 1/23/09 Our inspection revealed that these devices are adulterated under section 501(f)(1)(B)...Read More

Recipient: Encore Medical, LP Product:muscle stimulators and ultrasound devices. Date: 6/25/2008 1. Failure to establish and maintain adequate procedures to identify actions(s) needed to correct and prevent recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3). For example, your firm failed to identify the action(s) needed to correct failures and...Read More

Recipient: Steris Isomedix Inc Product:sterilizes medical devices. Date: 9/25/2008 We have reviewed your response dated July 16, 2008, and have concluded that it is inadequate because while you have opened a Correction and Preventative Action (CAPA) to address this issue, your corrective actions did not address any product that was processed prior to the initiation...Read More

Recipient: Stratec Medizintechnik Gmbh Product: bone densitometer. Date: 9/10/2008 Failure to adequately document acceptance activities, as required by 21 CFR 820.80(e). For example: The printouts contained in the DHR derived from computer software used to calibrate and test the finished device do not include the name of individual or contain the signature of the individual...Read More

Recipient: Mavidon Medical Products Product:Class II Mavidon Medical Electrode Jelly. Date: 8/8/2008 7. Failure to validate, according to an established protocol, computer software for its intended use, when that software is used as part of the Quality System or part of production as required by 21 CFR 820.70(i). The regulation under 21 CFR 820.70(i) requires...Read More

Recipient: GE Healthcare Integrated IT Solutions Product: Centricity Imaging and other Picture Archiving and Communication System (PACS) products Date: 8/12/2008 1. Failure to establish and maintain adequate procedures for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential...Read More

Recipient: Polymer Technology Systems, Inc.Product: CardioChek meters Date: 4/23/2008 The inspection revealed that the devices are adulterated under section 501(h) of the Act, 21 U.S.C. 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice...Read More

Recipient:iScreen, LLCProduct: Class II ophthalmic camera Date: 10/2/2007 This inspection revealed your ophthalmic cameras are adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)], in the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing...Read More

Recipient: Siemens Medical Solutions USA, Inc.. Product: molecular imaging diagnostic equipment device(s Date: 1/28/2008 This inspection revealed these devices are adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)], in the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity...Read More

Recipient: Spinal, USAProduct:Slimplicity Anterior Cervical Plate System, the Spinal USA Cement Restrictor and the Spinal USA Vertebral Body Replacement (VBR) System Date:12/7/2007 This inspection revealed these devices are adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)], because the methods used in, or the facilities or controls used for, their manufacture,...Read More

Recipient:Omron Healthcare, Inc. Product:diagnostic and therapeutic foreign manufactured medical devices Date:1/18/2008 This inspection revealed, that these devices are adulterated within the meaning of Section 501(h) of the Act [21 U.S.C. 351(h)], in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with...Read More

Recipient: Medico Labs, Inc. Product:drug products Date:4/16/2007 An inspection of your manufacturing facility was conducted from November 2 through November 16, 2006. During the inspection, our investigator documented deviations from the Current Good Manufacturing Practice (CGMP) Regulations, Title 21 Code of Federal Regulations, Parts 210 and 211 (21 CFR 210 and 211) for drug products...Read More

RecipientG&B Electronic Designs Limited Product: Tracklt and NicoletOne Ambulatory Electroencephalograph Recorder devices Date:4/24/2007 Failure to assure that when computers or automated data processing systems are used as part of the production or quality system the manufacturer shall validate computer software for its intended use according to an established protocol, as required by 21 CFR 820.70(i)....Read More

Recipient:Seryx, lnc Product: Signature Genetics software program Date:2/22/2007 This letter is in response to the Food and Drug Administration’s (FDA’s) review of your web site www.seryx.com, and the information you provided to The Office oft Vitro Diagnostic Devices (OIVD) in FDA’s Center for Devices and Radiological Health in a telephone conference on May 23, 2006...Read More

Recipient:BTI Filtration Product: mixed bed deionization (DI) tanks and carbon tanks that are used to provide treated water to dilute dialysate for use in hemodialysis. Date:2/27/2007 Failure to ensure the device master record includes or refers to the location of the device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications, as required...Read More

Recipient: MRL, Inc.. Product: automatic external defibrillators Date:12/8/06 We have reviewed your response to FDA-483 Observation # 12 and conclude that the plan was adequate; but without completion of the databases we have no assurance that its implementation will be adequate. 10. Failure to have production and process controls for automated processes, as required by...Read More

Recipient:Edwards Life Sciences, LLC Product: Swan-Ganz Continuous Cardiac Output (CCO) Catheter, Vigilance Monitors, and stents Date:2/5/2007 Failure to submit a supplemental report to FDA within 1 month of receipt of information that was known to you regarding a serious injury reportable under 21 CFR 803.50, as required by 21 CFR 803.56. For example, b) A...Read More

/Docs/GE-ConsentDecree-Customer_Letter_1-15-07.pdfRead More

Recipient: MRL Inc., a Welch Allyn Co..Product:Automatic external defibrillators Date:12/8/06 Failure to have production and process controls for automated processes, as required by 21 CFR 820.70(i). when computers or automated data processing systems are used as part of production or the quality system. A manufacturer is required to validate computer software for its intended use...Read More

Recipient: Patterson Technology Center Inc. Product:EagleSoft software Date:10/24/06 Failure to maintain procedures for receiving and evaluating complaints by a fomally designated unit; failure to establish and maintain adequate procedures for implementing corrective and preventive action; failure to establish and maintain adequate design control procedures to ensure design procedures address the planning, inputs, outputs, review, verification,...Read More

Recipient: Biolase Technology Inc.Product:Medical and dental lasers Date: 9/5/06 Design output procedures do not allow for an adequate evaluation of conformance to design input requirements as required by 21 CFR 820.30(d). Specifically, the software requirement input specifications for the Waterlase MD dental laser could not be individually verified and documented to show conformance to the...Read More

Recipient: Terumo Cardiovascular Systems.Product:Advanced Perfusion System (APS-1) Date:8/31/06 Failure to file a report of corrections or removals as required by Subpart B of 21 CFR 806. For example, your firm failed to promptly report to the FDA, as required by 21 CFR.806.10, the field correction action number NFC 813720, an action performed by your firm...Read More

Recipient: Sonotech Inc.Product:Ultrabio Sterile ultrasound coupling gel Date:8/8/06 Failure to validate processes that cannot be fully verified by subsequent inspection and test; failure to establish and maintain procedures for finished device acceptance; failure to maintain a device master record that referred to the location of the packaging and labeling specifications; failure to conduct quality audits...Read More

Recipient: Pointe Scientific Inc.Product:Hemoglobin A1c, Liquid Glucose Hexokinase, Liquid Alkaline Phosphatase, Liquid Auto Density Lipoprotein (Auto HDL) Cholesterol and other chemical analyzersr Date: 8/11/06 Failure to maintain procedures to ensure that the specified design requirements are met; failure to review all complaints to determine whether an investigation is necessary; failure to maintain procedures for implementing...Read More

Recipient:Aksys Ltd..Product:Aksys PHD Personal Hemodialysis System Date: 6/806 Our records do not show that you obtained marketing clearance or approval before you began offering your device for sale with a modified treatment length. The device was cleared via a premarket notification (510(k)) _____, on _____, with a specified treatment length of _____ using a _____....Read More

Recipient: Vapotherm IncProduct:”Vapotherm 20001″ respiratory gas humidifier Date: 6/12/06 Failure to verify and validate corrective and preventive actions to ensure that the action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4). For example, CAPA 05-032 includes a request to review cleaning protocols for improvement in existing cleaning...Read More

Company:Neurotone Systems Inc..Product: RelaxPak, Neurotone III and Neurotone III D Cranial Electrotherapy Stimulator Date: 4/10/2006 Failure to establish, and maintain procedures for monitoring and control of parameters for validated processes to ensure that the specified requirements continue to be met, as required by 21 CFR 820.75. [FDA-483 Item 4). Where the process cannot be fully...Read More

Recipient: National Genetics Institute.Product:HIV-1 and Hepatitis C virus nucleic acid tests Date: 1/17/2006 FDA District:Los Angeles District Office Failure to validate computer software used in production; failure to validate the quality system; failure to document validation activities and results; failure to make adequate provisions for monitoring laboratory test procedures and instruments; failure to maintain written...Read More

Recipient: LifeScan Inc.Product: OneTouch Ultra and OneTouch UltraSmart Blood Glucose Readers Date: 12/7/20055 Your October 6, 2005 response also describes the need to validate changes planned for your electronic complaint handling system. Again, a timeline for the completion of your validation study was not provided. The validation of your complaint handling system and the training...Read More

Recipient:Rite-Dent Manufacturing CorpProduct:Alginate impression material, zinc phosphate cement, polycarboxylate cement and other dental OTC devices Date: 12/2/05 Your firm failed to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purpose(s) and is capable of producing valid results. Each manufacturer shall maintain...Read More

Recipient: Shelhigh Inc.Product: Porcine Pulmonic Valve Conduits, Aortic Valve Conduits, Mitral Valve Conduits and other devices Date:12/14/05 Failure to obtain premarket approval prior to offering products for sale; failure to follow written procedures for design control; failure to follow written procedures for design validation to include a risk analysis; failure to validate corrective and preventive...Read More

Recipient: Gambro Dasco S.p.A.Product:Electromechanical dialysis control systems Date: 1/5/06 Letter acknowledges receipt of firm’s Oct. 24, 2005, response to FDA 483 but deems it inadequate. Letter notes that until alleged violations are corrected, the FDA may take steps to keeping imported devices in detention. Letter also includes alleged reporting violations. For example, review of the...Read More

Recipient:Guidant CorpProduct: TA-200 Thermal Angel Blood and IV Fluid Infusion Warmer Date:9/22/05 There are no corrective and preventive actions to change design control procedures to identify or prevent memory overflow or similar software programming problems from recurring. Software used as part of production and the quality system has not been fully validated for its intended...Read More

Recipient: Visual Telecommunications NetworkProduct: ViTelCare Trutle Home Patient Monitoring Systems Date: 9/13/05 Software used in the Turtle 600 and Turtle 800 devices has not been validated and a risk analysis has not been conducted for the finished devices [21 CFR 820.30(g)]. FDA District: Baltimore District OfficeRead More

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Recipient: Tepnel Diagnostics Inc.Product:Elucigene genetic assays Date: 8/26/05 FDA District: New England District OfficeBased on information on your website, these devices do not adhere to the restrictions on the sale, distribution, and use of ASRs. Your website makes specific analytical and performance claims such as that your devices can detect multiple mutations per device and...Read More

Recipient: Boston Scientific Corp.Product:Vaxcel Low Profile Infusion Ports, Taxus paclitaxel drug eluting stents and Symmetry balloon dilation catheters Date: 8/10/05 Failure to analyze processes, work operations and other sources of quality data to identify existing and potential causes of non-conforming product as required by 21 CFR 820.100(a)(1). For example, we observed the release and actual...Read More

Recipient: Uroplasty Inc.Product: Investigational devices Date: 7/19/05 The inspectional report notes that review of subject records across five (5) investigational sites revealed that study procedures were initiated on 30 subjects prior to obtaining the informed consent of these individuals as required by the regulations at 21 CFR Part 50. The inspectional report further notes that...Read More

Recipient: Hitachi Medical Systems America Inc.Product: Magnetic Resonance Imaging Systems Date: 7/13/05 On April 20, 2004, your firm issued a Software Release Bulletin instructing the service representatives to install a software upgrade to all Altaire/AIRIS MRI systems. This upgrade fixed the problem of images from one patient’s study being co-mingled with another patient’s study. Your...Read More

Recipient:Con-Med Corp.Product: Irrigation pumps, hand pieces and surgical drills Date: 6/29/05 Software flags were added to rechargeable batteries after complaints were received referencing the battery’s depletion during surgery. No verification or validation of this corrective action was conducted. FDA District: Florida District OfficeRead More

Recipient: Millennium Dental Technologies IncProduct: Medical devices Date: 6/7/05 Our inspection found the following device QSR deficiencies Software used as part of the quality system has not been validated for its intended use according to an established protocol. Specifically, you are using a software system for your procedures that allows procedures to have inconsistent effective,...Read More