FDA Warning Letter: Missing Ongoing Stability Program for Biotech APIs

In March 2025, the U.S. FDA issued a Warning Letter (WL) to the Indian company "Aspen Biopharma Labs Private Limited" after having inspected its site in September 2024.

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

• "Failure to design and construct buildings and facilities used in the manufacture of your API in a manner to minimize potential contamination, facilitate appropriate cleaning, maintenance, and operations."
• "Failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes and failure to adequately validate written procedures for the cleaning and maintenance of equipment."
• "Failure to have originals or copies of records readily available and promptly retrievable during the retention period."
• "Failure to design a 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."

According to U.S. FDA Warning Letter, the firm failed to maintain an on-going stability program for their APIs. This is based on the fact that the company did not have adequate data supporting the reported retest dates.

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 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. Finally, the Warning Letter mentions that the U.S. FDA placed the firm on import alert und recommended in January 2025 to recall their products from the US market.

To view the complete list of violations and the conclusion given by the U.S. FDA, please see the Warning Letter Aspen Biopharma Labs Private Limited.