FDA 483 - Alembic Pharmaceuticals Limited (Units I and II) - May 31, 2025

An FDA inspection conducted from May 26-31, 2025, at Alembic Pharmaceuticals Limited (Units I and II), an Active Pharmaceutical Ingredient (API) manufacturer in Gujarat, India, revealed significant deviations from current Good Manufacturing Practices. The inspection led to four key observations documented in an FDA Form 483.

The firm failed to conduct timely and thorough laboratory investigations, particularly regarding increasing impurity levels in API stability studies, and did not adequately justify discrepancies in retest results. Additionally, analytical test procedures used for stability testing of US-marketed APIs were not sufficiently validated, lacking complete degradation pathway data for multiple products.

Facility and equipment maintenance were also cited; non-dedicated production equipment was found in disrepair, containing residual materials while tagged as "ready for use," indicating potential for product contamination. Specific issues included powdery residues, damaged surfaces, and corrosion on critical equipment.

Finally, the Quality Unit demonstrated a lack of oversight in document control, with employees recording GMP activities on uncontrolled papers, including an unlogged equipment leakage. Alembic Pharmaceuticals Limited is expected to provide a comprehensive response detailing corrective and preventive actions to address these observations and ensure cGMP compliance.