FDA 483 - Shilpa Pharma Lifesciences Limited - July 26, 2019

The FDA inspection of Shilpa Medicare Limited in Raichur, India, revealed significant deficiencies across quality systems, facilities, equipment, and laboratory controls. Key issues included inadequate investigations into out-of-specification results and power failures, missing manufacturing equipment, and poor equipment maintenance and cleaning validation. Additionally, the firm failed to validate computer systems and ensure proper instrument calibration and verification procedures, indicating a lack of robust control over critical API manufacturing and quality processes.