FDA 483 - Megafine Pharma (P) Limited - May 08, 2023

An FDA inspection of Macafine Pharma (P) Ltd, an Active Pharmaceutical Ingredient manufacturer in Vapi, Gujarat, revealed significant deficiencies in laboratory controls and quality system processes. The firm failed to adequately test water used in API intermediate manufacturing for microbial content and TOC, and did not properly identify microbial colonies during water system validation. Additionally, the inspection found that investigations into deviations and failures were not timely, lacked proper justification for extensions, and were not consistently expanded to include other potentially affected batches or components, with many CAPAs remaining open for extended periods.