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warningletter

Software Warning Letters

The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations at Denterprise International, Inc., 100 E. Granada Blvd. Ste. 219, Ormond Beach, Florida, from May 1, 2019 to May 6, 2019. During the inspection, an FDA investigator determined that your firm is a specifications developer, manufacturer of the...
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The FDA has uncovered circumstances of drug quality data and information being inaccurate, which can mask problems and failures. Patients cannot be assured of the safety and effectiveness of their medication when data has been altered. One critical way to help ensure product quality is to prevent data integrity lapses from the outset. Over the...
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The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations, TALON, an S&S Technology Company, located in Houston, TX, from March 11 – 28, 2019. During the inspection, an FDA investigator determined that your firm is a medical device manufacturer of various Class I & II medical equipment,...
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During an inspection of your firm located in Tuttlingen, Germany, on January 25, 2012, through January 27, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures non-powered endoscopic grasping/cutting instruments. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these...
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Advanced Botanical Consulting & Testing Inc dba ABC Testing Product: Drugs Date: 6/11/19 CMS Number: 572991 The U.S. Food and Drug Administration (FDA) inspected your contract testing laboratory, Advanced Botanical Consulting and Testing Inc. dba ABC Testing (FEI 3003693795) at 1169 Warner Ave, Tustin, California, from November 1 to 13, 2018. This warning letter summarizes...
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Zeller Power Products, LLC Product: Medical Device Date: 5/9/19 CMS Number: 570909 The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations, Zeller Power Products, LLC., located at 6585 Arville Street, Suite A, Las Vegas, NV, from November 6 – 9, 2018. During the inspection, an FDA investigator...
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Rechargeable Power Energy North America, LLC Product: Medical Device Date: 5/9/19 CMS Number: 570911 The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations, Rechargeable Power Energy North America, LLC located in Las Vegas, Nevada, from November 5 – 9, 2018. During the inspection, an FDA investigator determined...
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Datascope Corporation Product: Medical Device Date: 2/6/19 The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations at 1300 Macarthur Blvd., Mahwah, NJ, from July 30, 2018 through October 3, 2018. During the inspection, FDA investigators determined that your firm is a of intra-aortic balloon pumps (IABPs) and Cardiosave...
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Glanced through the latest FDA warning letters today.  From the FDA Medical Device & Radiological Health Operations West/Division 3 I see the inspector pointing out “This design validation also fails to include software validation [emphasis mine] to assure software will perform as intended and will not prevent safe operation by the user.”   Of course this is...
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Datascope Corporation Product: drug manufacturing facility Date:9/11/18 Purchasing controls; complaint investigations 1. Failure to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a). Specifically, your firm performed a supplier assessment from (b)(4) for Circulatory Technology and approved (“(b)(4)”) the use of...
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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 posted on this site for the years listed. Some of the newest warning letters on the site may not be included since we only update this...
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Pharmaceutical Laboratories and Consultants, Inc. Date:8/29/18 This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211. Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of...
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Pharmaceutical Laboratories and Consultants, Inc. Date:8/29/18 This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211. Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of...
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Pharmaceutical Laboratories and Consultants, Inc. Product: testing laboratory Date:8/29/18 This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211. Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within...
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Yuki Gosei Kogyo Co., Ltd. Date:8/10/18 Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failure to have adequate controls to prevent omission of data. Your firm’s controls over your HPLC systems are inadequate. Some HPLC systems did not have audit trail capability or audit trails enabled....
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Yuki Gosei Kogyo Co., Ltd. Date:7/17/18 Data Integrity Remediation: Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. We strongly recommend that you retain a qualified consultant to assist in your remediation. In response to this letter, provide the...
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Company: Baxter (Claris Injectables Ltd.) Date: 7/5/18 Data Integrity Remediation: Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. In response to this letter provide the following. A. A comprehensive investigation into the extent of the inaccuracies in data,...
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Baxter (Claris Injectables Ltd.) Product: drug manufacturing facility Date:7/5/18 Data Integrity Remediation Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. In response to this letter provide the following. A. A comprehensive investigation into the extent of the inaccuracies...
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The firm's quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs manufactured - remediation required
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Significant violations of CGMP regulations due to failure to maintain adequate written records of major equipment maintenance and data integrity issues
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Company: Denttio, Inc.Product: digital x-ray image receptors and intraoral microscope/cameras Date:2/23/2017 Failure to perform device software validation and risk analysis as required by 21 CFR 820.30(g). For example, you do not have records to demonstrate that your Imaging Software used with the Tio-H Digital X-Ray Sensor has been validated. You do not have records to...
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Company: Morton Grove Pharmaceuticals, Inc. Date:1/17/2017 Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)). Data Integrity Remediation Your quality system does not adequately ensure the accuracy and integrity of data to...
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FACTA Farmaceutici S.p.A Product: drug manufacturing facility Date:1/13/2017 1. 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)). For multiple sterile drug product lots, your original data showed failing results, but data you reported showed passing results....
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Zyno Medical LLCProduct: infusion pumps Date:12/5/2016 Failure to establish and maintain procedures to control product that does not conform to specified requirements, and to address the identification, documentation, evaluation, segregation, and disposition of nonconforming product, as required by 21 CFR 820.90(a). For example: Your firm did not open a non-conforming report (NCR) on 7/30/15, when...
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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 Part 11 related warning letter excerpts included on this site as of the date above.  This file is updated periodically, but for the most recent warning letters between these updates, do text...
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Adamson Analytical Laboratories, Inc.Product: finished pharmaceuticals Date: 8/2/2016 This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, 21 CFR parts 210 and 211, and significant deviations from CGMP for active pharmaceutical ingredients (API). Your firm failed to exercise appropriate controls over computer or related systems to assure that...
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Zimmer Biomet Holding, Inc.Product: iAssist Knee System Date: 5/27/2016 8. Failure to submit a Report of Correction or Removal for a medical device correction or removal initiated to reduce a risk to health or to remedy a violation of the Act caused by the device, which may present a risk to health, as required by...
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Recipient:  Polydrug Laboratories Pvt. Ltd. Corporate Office Product:  Pharmaceuticals Date: 4/11/2016 Failure of computerized systems to have sufficient controls to prevent unauthorized access or changes to data. Your firm’s computer system for entering test results and storing certificates of analysis (CoA), which document whether a drug meets specifications, does not have sufficient controls to prevent...
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http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077862.htm
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/docs/scpred/FDA-2015WL-483DataPresentationV_1312016.pdf
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Cadila Healthcare Limited.Product: pharmaceutical manufacturing facilities Date: 12/23/2015 Our investigators observed specific violations during the inspection, including, but not limited to the following. Your firm failed to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data. a. Your firm failed to adequately control the use of computerized systems in the...
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Sun Pharmaceuticals Industries Ltd..Product: pharmaceutical manufacturing facilities Date: 12/17/2015 Our investigators observed specific violations during the inspection, including, but not limited to the following. 6. Your firm failed to establish appropriate controls over computers and related systems to assure that changes in master production and control records or other records are instituted only by authorized...
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Unimark Remedies LtdProduct: active pharmaceutical ingredients Date: 9/28/2015 Failure to prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data. Your laboratory systems lacked access controls to prevent raw data from being deleted or altered. For example: a. During the inspection, we noted that you had no unique...
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Mylan.Product: ECG Check Application and ECG Check Wireless Lead Cardiac Monitor Date: 8/7/2015 1. Failure to establish and maintain design validation procedures to ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions, as required by 21 CFR 820.30(g). 1. Your...
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Mylan.Product: pharmaceutical manufacturing facility Date: 8/6/2015 Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel can change master production and control records, or other records (21 CFR 211.68(b)). Your Siemens computer-based BMS and NVPMS do not require passwords to access the network and servers. Your contractors?...
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http://www.consumer.ftc.gov/blog/can-your-app-really-do
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Mahendra Chemicals..Product: pharmaceutical manufacturing facility Date: 7/13/2015 Failure to prevent unauthorized access or changes to data, and to provide adequate controls to prevent omission of data. Your laboratory systems lacked access controls to prevent raw data from being deleted or altered. For example, a) There is no assurance that you maintain complete electronic raw data...
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VUAB Pharma a.s..Product: pharmaceutical manufacturing facility Date: 5/27/2015 ailure to prevent unauthorized access or changes to data and to provide adequate controls preventing data omissions. Our inspection noted that your firm did not retain complete raw data from testing performed to assure the quality of (b)(4), API. Specifically, our inspection revealed your firm did not...
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Soft Computer Consultants, Inc.Product: Class I/II software systems Date: 4/30/2015 1. Failure to adequately establish procedures for CAPA as required by 21 CFR 820.100(a). Specifically, A. Product Change Controls (PCCs) which are corrective and preventive actions for handling software coding defects do not always include investigating the cause of all nonconformities relating to product, processes...
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Quality Electrodynamics, LLC..Product: cois used in conjunction with MRI scanners . Date: 4/10/2015 Failure to document validation activities, as required by 21 CFR 820.75(a). Specifically, The setting (temperature and line speed) used during the validation studies for the reflow oven, which is part of the SMT (Surface Mount Technology) line, to determine the optimum settings...
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Recipient: Yunnan Hande Bio-Tech. Co. Ltd..Product: active pharmaceutical ingredients . Date: 4/6/2015 Our investigators observed specific deviations during the inspection, including, but not limited to, the following: 1. Failure to prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data. You lacked controls to prevent the unauthorized manipulation...
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Novacyl (Thailand), Ltd.Product: active pharmaceutical ingredients (APIs) Date: 2/27/2015 3. Failure to prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data. The inadequate controls over access to your data raise questions about the authenticity and reliability of your data and the quality of the APIs you produce....
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XZeal Technologies, Inc.Product: XZeal Dental X-Ray Unit Z70 Date: 2/20/2015 1. Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). For example: b. Your firm has not established and maintained documentation in support of Section 4.6 – Design Validation of the Product – Conception and Development, PR0-04.01,...
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Inovo, IncProduct: AccuPulse Model 6505 oxygen conserver, Bonsai Velocity oxygen conserver, Evolution oxygen conserver, Evolution with Motion oxygen conserver, SmartDose oxygen conserver, Smart Does Mini oxygen conserver, Oxymizer Disposable oxygen conservers, and oxygen Regulators. Date: 2/19/2015 4. Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). Specifically,...
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Micro Labs LimitedProduct: pharmaceutical manufacturing facility Date: 1/9/2015 1. 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)). a) During the inspection, your management admitted that employees in both of your Quality Control (QC) laboratories had frequently...
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Novacyl Wuxi Pharmaceutical Co., Ltd. .Product: pharmaceutical manufacturing facility Date: 12/19/2014 1. Failure to manage laboratory systems with sufficient controls to ensure conformance to established specifications and prevent omission of data. Our inspection revealed serious deficiencies related to your documentation practices, including missing raw data. It is a basic responsibility of your quality unit to...
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Customed Inc.Product: medical devices, including convenience packs for surgical procedures Date: 1/9/2015 Failure to validate the defined user needs and intended uses of the (b)(4) used as part of the quality system according to an established protocol, as required by 21 CFR 820.70(i). Specifically, your firm implemented (b)(4) to track product inventory (incoming materials, finished/released...
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