Missing Ongoing Stability Studies for APIs : FDA Warning Letter

In April 2024, the U.S. FDA issued a Warning Letter concerning Antaria Pty. Ltd., an Australian company, following an inspection conducted in November 2023.

The Warning Letter highlights several violations of CGMP regulations for active pharmaceutical ingredients (APIs), including:

• Inadequate investigation and documentation of out-of-specification results.
• Failure to conduct appropriate laboratory tests for each batch of API to ensure compliance with specifications.
• Lack of complete laboratory control records.
• Absence of an adequate stability testing program for monitoring API stability characteristics.

Of particular concern is the absence of stability data, with the manufacturer failing to implement a proper stability program for the API. This violates the ICH Q7 guideline, which mandates ongoing stability studies.

The Warning Letter concludes by stating that FDA approval for new applications or supplements may be withheld until compliance is confirmed. A reinspection may also be necessary. Additionally, adherence to the ICH Q7 guideline during API manufacturing operations is emphasized.

For further details, refer to the complete Warning Letter issued to Antaria Pty. Ltd. by the U.S. FDA.