FDA 483 - Grant Industries, Inc. - August 21, 2020

An FDA inspection of Grant Industries, Inc., an API manufacturer in Elmwood Park, NJ, revealed significant deficiencies in their quality system. Observations included missing personnel training records, failure to follow established quality unit procedures for complaint handling, cleaning validation, and laboratory practices, and inadequate control over computer-related systems. These issues indicate a lack of robust quality oversight and compliance with cGMP requirements.