USFDA Flags Major Lapses at Aspen Biopharma’s API Facility

The U.S. Food and Drug Administration (USFDA) has issued a warning letter to Aspen Biopharma Labs for significant violations at its active pharmaceutical ingredient (API) manufacturing plant in Rangareddy, Telangana. The inspection, conducted from September 16 to 21, 2024, uncovered multiple Current Good Manufacturing Practice (CGMP) deviations.

Key findings include:

• Inadequate facility design, with manufacturing areas exposed to the outdoor environment, increasing contamination risks.

• Failure to validate manufacturing processes and properly qualify equipment used in drug production.

• Lack of a documented, ongoing stability testing program to monitor API stability characteristics.

The USFDA noted that Aspen Biopharma deregistered the facility on January 6, 2025, but it’s unclear whether the company intends to cease production for the U.S. market. The agency has requested clarification on future manufacturing plans.

A warning letter signifies serious regulatory violations and requires prompt corrective actions. The USFDA will verify the adequacy of the company’s responses to ensure compliance.