FDA 483 - Akorn Operating Company LLC - March 28, 2016

Akorn Inc, a sterile drug manufacturer in Somerset, NJ, was cited for multiple deficiencies during an FDA inspection. The observations highlight significant issues across quality control, including failures in preventing microbiological contamination, inadequate investigations, and a deficient stability testing program. Additionally, the firm was cited for poor data documentation practices, unapproved changes to validation protocols, and a lack of proper method verification, transfer, and validation for various drug products and cleaning processes.