FDA 483 - ABRYL LABORATORIES PRIVATE LIMITED - January 22, 2022

An FDA inspection of Abryl Laboratories Private Limited in Derabassi, Punjab, India, a sterile manufacturer, revealed significant deficiencies across multiple areas. The firm failed to adequately validate aseptic and sterilization processes, maintain proper environmental controls, and ensure robust laboratory and quality control systems. These issues collectively indicate a lack of sterility assurance for their drug products.