1-3 July 2024
Vienna, Austria
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:
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.