FDA 483 - Apex Pharmaceuticals Inc. - April 18, 2019

An FDA inspection of Apex Pharmaceuticals Inc. in South Plainfield, NJ, revealed significant deficiencies across its manufacturing operations. Observations included inadequate cleaning and maintenance of equipment, insufficient laboratory controls for testing procedures and data integrity, and a lack of consistent GMP training for employees. These issues indicate a failure to ensure drug product quality, identity, strength, and purity.