FDA 483 - Chartwell Pharmaceuticals Amityville, LLC - December 21, 2022

An FDA inspection of Akorn Operating Company, LLC in Amityville, NY, a manufacturer of sterile and non-sterile drug products, revealed significant deficiencies across multiple areas. The firm failed to thoroughly investigate out-of-specification reject rates and media fill failures, maintain equipment properly, follow written procedures for requalification, and ensure adequate component sampling. Additionally, the facility exhibited unsanitary conditions and incomplete batch production records, indicating a systemic lack of control over manufacturing processes and quality assurance.