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 requiredRead More

Significant violations of CGMP regulations due to failure to maintain adequate written records of major equipment maintenance and data integrity issuesRead More

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...Read More

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...Read More

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....Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077862.htmRead More

/docs/scpred/FDA-2015WL-483DataPresentationV_1312016.pdfRead More

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...Read More

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...Read More

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...Read More

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...Read More

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?...Read More

http://www.consumer.ftc.gov/blog/can-your-app-really-doRead More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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....Read More

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,...Read More

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,...Read More

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...Read More

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...Read More

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...Read More

Trifarma S.p.A.Product: active pharmaceutical ingredients (APIs) Date: 7/7/2014 1. Failure to maintain complete data derived from all testing and to ensure compliance with established specifications and standards pertaining to data retention and management. Your firm did not retain complete raw data from testing performed to ensure the quality of your APIs. Specifically, your firm deleted...Read More

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...Read More

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...Read More

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)...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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.Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More