FDA 483 - SRI Krishna Pharmaceuticals Ltd - Unit I - April 14, 2025

Sri Krishna Pharmaceuticals Limited Unit I, an API manufacturer located in Hyderabad, Telangana, India, underwent an FDA inspection from April 14 to April 18, 2025. The inspection identified significant issues related to facility maintenance and contamination control, as documented in the FDA Form 483.

Key violations included the failure to maintain clean and contamination-free manufacturing environments. Observations noted mold-like substances on ceilings above production lines, dust and particles in clean rooms, and improperly sealed light fixtures, all of which pose contamination risks. Additionally, pressure monitoring systems were found to be malfunctioning, potentially allowing microorganisms and airborne particles into cleanrooms.

The inspection also highlighted inadequate precautions during API handling, with operators not following proper gowning procedures, leading to potential contamination of products. This was evidenced by complaints of foreign matter in secondary packaging.

The FDA expects Sri Krishna Pharmaceuticals to address these deficiencies by implementing corrective actions to ensure compliance with Good Manufacturing Practices (GMP). This includes improving cleaning procedures, ensuring proper maintenance of facilities and equipment, and reinforcing staff training on contamination prevention. The firm is advised to submit their corrective action plans to the FDA for review and approval. Failure to comply may result in further regulatory actions.