FDA Warning Letter: Data Integrity issues while manufacturing APIs

In February 2024, the U.S. FDA issued a Warning Letter to the Chinese company "Sichuan Deebio Pharmaceutical Co. Ltd." after having inspected its site in September 2023.

The significant violations of CGMP regulations for active pharmaceutical ingredients (APIs), which are mentioned in the Warning Letter, are listed as follows:

  • "Failure to follow and document laboratory controls at the time of performance, and failure to document and explain any departures from laboratory procedures."
  • "Failure of your quality unit to exercise its responsibility to ensure the API and intermediates manufactured at your facility are in compliance with CGMP."

Especially, the first observation mentioned in the Warning Letter is related to the lack of microbiology laboratory Data Integrity. It is listed as an example that the firm failed to have "CGMP activities documented at the time of performance". Good documentation practices are useful tools to support Data Integrity and validity of the respective records.

According to U.S. FDA Warning Letter, the firm's quality systems are inadequate. It is mentioned that the company failed to "document control and retention of printouts and electronic records for USP API testing".

The observed findings resulted in a long list of Data Integrity remediation activities and CAPA measurements requested.
Coming to the final conclusion mentioned in the Warning Letter, the U.S. FDA strongly recommends engaging a CGMP consultant to support the company in aligning their systems with CGMP requirements. Additionally, the U.S. FDA clearly states that the requirements mentioned in the ICH Q7 guideline need to be considered during API manufacturing operations.

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

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