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Software Warning Letters

STERIS Corporation Product:facility sterilizes medical devices Date:5/22/2014 1. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100. Your CAPA procedure, PROC-00007, Revision 19, is deficient in that it does not adequately describe how to identify, correct and prevent the recurrence of nonconforming product and other...
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Sun Pharmaceutical Industries Limited Product: pharmaceutical manufacturing facility Date:5/7/2014 1. Failure to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards. our firm frequently performs ?unofficial testing? of samples, disregards the results, and reports results from additional tests. For example, during stability testing, your...
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USV Limited Product: pharmaceutical manufacturing facility Date:3/6/2014 1. Failure to maintain complete and accurate laboratory test data generated in the course of establishing compliance of your APIs to established specifications and standards. a. There was no written explanation for deletion events observed on audit trails for your standalone HPLC units. Your standard operating procedures (SOPs)...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. It contains all software and computer related warning letter excerpts included on this site. Some of the newest warning letters on the site may not be included since we only update this comprehensive document periodically. This compilation is provided...
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Wockhardt Limited Product: pharmaceutical manufacturing facilities Date:11/25/2013 Investigators from the U.S. Food and Drug Administration (FDA) identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug products to be adulterated within the meaning of Section 501(a)(2)(B) of...
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General Hearing Instruments, Inc.. Product: ready-wear-air conduction hearing aids Date: 9/18/2013 This inspection revealed these devices are adulterated within the meaning of Section 501(h) of the Act [21 USC 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 Current...
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Jabones Pardo S.A..Product: pharmaceutical manufacturing facility Date: 8/22/2013 an investigator from the U.S. Food and Drug Administration (FDA) identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug products to be adulterated within the meaning of Section...
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RPG Life Sciences LimitedProduct: pharmaceuticals. Date: 5/28/2013 Our investigator observed specific violations during the inspection, including, but not limited to, the following: Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)). Additionally, during an audit of the...
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Puget FDA Mobile App Compliance LetterProduct:Letter to Biosense Technologies Private Limited concerning the uChek Urine Analyzer Date: 5/21/2013 It has come to our attention that you are currently marketing the uChek Urine analyzer, which is intended for use with Siemens Multistix SG10, Siemens Multistix SG, Siemens Uristix, Bayer Diastix, and Bayer Keto-Diastix reagent strips for...
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Puget Sound Blood Center and ProgramProduct: blood and blood products Date: 3/16/2013 During the inspection, FDA investigators documented significant deviations from applicable current Good Manufacturing Practice (cGMP) regulations for blood and blood products, Title 21, Code of Federal Regulations (21 CFR), Parts 606, 610 and 640 and the cGMP regulations for finished pharmaceuticals, 21 CFR...
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The total number of FDA software, computer system, and electronic records warning letters in 2012 is approximately 30 which is up from 18 in 2011 and fewer in 2009 and 2010. This is based on the keyword searches we perform on a regular basis but is not guaranteed to be comprehensive.
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Recipient:  Shamrock Medical Solutions Group LLC . Product:  Pharmeceuticals Date: 6/15/2012 Investigators from the Food and Drug Administration (FDA) identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug products to be adulterated within the meaning of...
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Recipient:  American Optisurgical Inc. Product:  TX1 Tissue Removal System Date: 6/14/2012 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...
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Recipient: BTS S.p.A. Product: FreeEMG and PocketEMG Date: 5/10/2012 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 the...
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Recipient: Mediagnost GmbH. Product: Human Growth Hormone diagnostic kits Date: 5/8/12 Failure to establish and maintain adequate procedures to control all documents, as required by 21 CFR 820.40. For example: a. There are no procedures that address the control of electronic records. b. Access to two computer workstations that include in-process test data, finished device...
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Recipient:Community Blood Centers of Florida, Inc. . Product:blood and blood components Date: 4/7/2012 The Food and Drug Administration (FDA) conducted an inspection of your firm, Community Blood Centers of Florida, Inc., from September 1, 2011 – December 19, 2011. During the inspection, FDA investigators documented deviations from applicable current Good Manufacturing Practice for Finished Pharmaceuticals...
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Recipient:Biochem Laboratories Inc. Product:TX1 Tissue Removal System Date: 2/17/2012 Your firm has failed 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)]. For example: a. Your firm did not put in place requirements...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The attached pdf file contains all software and computer related warning letter excerpts included on this site. Some of the newest warning letters on the site may not be included since we only update this comprehensive document periodically. This...
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Recipient: CuraeLase, IncProduct:CL 1000 IR Laser System Date: 12/9/2011 Quality System Regulation Concerns We also note the following concerns regarding Quality System (QS) regulation requirements (21 CFR Part 820): 6. Failure of the DMR for each device type to include or refer to the location of the device specifications, including software specifications, as required by...
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Recipient: Beckman Coulter, Inc.Product: Class II diagnostic chemistry analyzers, reagents, calibrators and controls Date: 8/9/2011 Failure to establish and maintain adequate design validation procedures to ensure that devices conform to defined user needs and intended uses; to ensure proper risk analysis is completed; and to ensure the results of the design validation, including identification of...
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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....
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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...
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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...
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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...
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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....
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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...
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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...
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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...
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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)...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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,...
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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...
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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...
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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)....
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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...
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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...
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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...
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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...
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/Docs/GE-ConsentDecree-Customer_Letter_1-15-07.pdf
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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...
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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,...
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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...
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