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

Need Your Input!

We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course?  What are the least favored (not workable) months?
Please respond by email to

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