FDA 483 - ABRYL LABORATORIES PRIVATE LIMITED - November 20, 2023

An FDA inspection of Abryl Laboratories Private Limited, a sterile drug manufacturer in Derabassi, Punjab, India, revealed significant deficiencies across multiple areas. The firm was cited for inadequate laboratory records, failure to thoroughly investigate discrepancies and out-of-specification results, and a lack of written and followed quality control unit procedures. Additionally, the inspection found issues with manufacturing process controls, including cleaning and process validation, and insufficient employee training for critical operations.