FDA WARNING_LETTER - Aspen Biopharma Labs Private Limited - September 21, 2024

The FDA inspected Aspen Biopharma Labs Private Limited in Hyderabad, India, from September 16-21, 2024, identifying significant Current Good Manufacturing Practice (CGMP) deviations for active pharmaceutical ingredients (API), rendering their API adulterated.

Key violations include: 1. **Facility Design and Construction:** The facility was in disrepair, open to the outdoor environment, and lacked proper segregation for high pharmacological activity or toxic materials, including (b)(4) drugs, which were manufactured in a common area. The firm admitted to manufacturing in an annex without proper segregation. 2. **Process and Cleaning Validation:** The firm failed to validate manufacturing processes for commercial-size API lots, relying on development lot studies with different equipment. Cleaning procedures were inadequate, with observations of unclean equipment labeled "Cleaned." 3. **Data Integrity:** The firm admitted to backdating a QC lab document and shipping commercial drugs to the U.S. without appropriate original data, indicating inadequate document control. 4. **Stability Testing Program:** The stability program was insufficient, lacking adequate data to support retest dates for drugs shipped to the U.S.

The FDA found the firm's October 11, 2024, response to the Form FDA 483 inadequate due to insufficient detail or evidence of corrective actions.

Required corrective actions include providing detailed plans for facility design to prevent contamination, evidence of completed process and cleaning