FDA 483 - Anicare Pharmaceuticals Pvt Ltd. - January 20, 2023

Anicare Pharmaceuticals Pvt Ltd. in Navi Mumbai, India, was inspected and received a Form 483 with nine observations indicating significant deficiencies in their manufacturing and quality control processes. Key issues include inadequate Out-of-Specification investigations, lack of proper quality unit oversight and line clearance, and insufficient data integrity controls for analytical instruments. Additionally, the firm exhibited poor facility sanitation, incomplete laboratory records, improper raw material identification, inadequate equipment cleaning validation, and a failure to test for objectionable microorganisms, compounded by inappropriate storage of finished drug products.