FDA 483 - Sharp Mint Limited - January 31, 2020

During an inspection of Sharp Mint Limited, an Active Pharmaceutical Ingredient (API) manufacturer in Delhi, FDA investigators observed significant deficiencies in the firm's quality and laboratory systems. Issues included a lack of an ongoing stability testing program, inadequate evaluation of procedural changes, and failures in testing incoming packaging materials and employee GMP training. Additionally, the firm failed to appropriately verify analytical methods and qualify reference standards for API release.