Warning Letter – Wuxi Medical Instrument Factory

Wuxi Medical Instrument Factory.
Product: drug manufacturing facility
Date: 9/7/2017
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 section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B). Your firm does not exercise appropriate controls over computer related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel [21 C.F.R. 211.68(b)]. For example: Your firm failed to maintain adequate written records of major equipment maintenance (21 CFR 211.182). During the inspection, you provided our investigator with records documenting (b)(4) sanitization of your (b)(4) loop. The records, covering January to March, 2017, were signed by two employees, and indicated that sanitization had been completed and verified contemporaneously throughout this period. However, our investigator found that these operations were not documented at the time of their actual performance, but were instead created and completed on March 7, 2017, the second day of the inspection. Your response acknowledges this data integrity issue and indicates that you have taken some remediation steps.

In response to this letter, provide:

  1. A comprehensive investigation into the extent of the inaccuracies in data records and reporting. Identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies. Describe all parts of your facility’s operations in which you discovered data integrity lapses, and provide an evaluation of the nature of the data integrity deficiencies.
  2. A current risk assessment of the potential effects of the observed failures on the quality of your drugs.
  3. A management strategy for your firm that includes the details of your global corrective action and preventive action plan. Your strategy should include: a comprehensive description of the root causes of your data integrity lapses, the interim measures you have taken or will take to protect patients and to ensure the quality of your drugs while remediation is ongoing, and the long-term measures you will take to ensure the integrity of your company’s data. Include a status report for any of the above activities already underway or completed.

FDA District: CDRH

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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