FDA Warning Letter: Missing Ongoing Stability Studies for APIs

In April 2024, the U.S. FDA issued a Warning Letter on its webpage to the Australian company "Antaria Pty. Ltd." after having inspected its site in November 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 adequately investigate and document out-of-specification results and implement appropriate corrective actions."
  • "Failure to ensure that, for each batch of API, appropriate laboratory tests are conducted to determine conformance to specifications."
  • "Failure to have laboratory control records that include complete data derived from all laboratory tests conducted to ensure your API complies with established specifications and standards."
  • "Failure to design an adequate documented, on-going stability testing program to monitor the stability characteristics of API and to use the results to confirm appropriate storage conditions and retest or expiry dates."

Especially, the fourth observation mentioned in the Warning Letter is related to the lack of stability data. It is listed that the manufacturer failed to have an appropriate stability program in place for the API in scope. The ongoing stability studies and the respective tests are missing for three consecutive timepoints. According to the ICH Q7 guideline, section 11.54 "at least one batch per year of API manufactured (…) should be added to the stability monitoring program and tested at least annually to confirm the stability."

Coming to the final conclusion mentioned in the Warning Letter, the U.S. FDA may withhold approval of new applications or supplements of the company until the U.S. FDA confirms the compliance of the facility with CGMP. A reinspection could be possible. 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 Antaria Pty. Ltd.

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