FDA Warning Letter: Missing Stability Studies

In December 2023, the U.S. FDA issued a Warning Letter to the US American company "Inopak, Ltd." after having inspected its site in July and August 2023.

The significant violations of cGMP regulations for drug product, which are mentioned in the Warning Letter, are listed as follows:

  • "Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d))."
  • "Your firm failed to assure that the drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a))."

According to U.S. FDA Warning Letter, the firm failed to maintain an ongoing stability program for their drug product. This is caused by the fact that the company stopped working with their contract laboratory which was in charge for stability testings. After canceling the co-operation with the lab, "Inopak, Ltd." missed to establish an own ongoing stability program or to subcontract these obligations to another laboratory to ensure the quality of their product throughout its life cycle (until the established expiry date).

The observed findings resulted in a list of remediation activities and CAPA measurements requested.
Coming to the final conclusion mentioned in the Warning Letter, the U.S. FDA may refuse new applications listing the company as drug manufacturer and export certificates until the site has addressed all observations and fully complies with cGMP requirements, which might be checked by a further inspection.

To view the complete list of violations and the conclusion given by the U.S. FDA, please see the Warning Letter Inopak, Ltd.

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