FDA 483 - Chartwell Pharmaceuticals Amityville, LLC - February 13, 2019

An FDA inspection of Hi-Tech Pharmacal Co. Inc., an AKORN Company, in Amityville, NY, revealed significant deficiencies in their sterile and non-sterile drug manufacturing operations. Observations included inadequate equipment maintenance records, improper aseptic processing practices, failure to follow the written stability testing program, and insufficient testing of containers and closures. These issues led to numerous customer complaints regarding product quality.