FDA 483 - Acella Pharmaceuticals, LLC - September 17, 2021

An FDA inspection of Acella Pharmaceuticals, LLC in Alpharetta, GA, revealed significant deficiencies across its quality management system. The firm failed to ensure proper quality control unit responsibilities, thoroughly investigate product discrepancies, adhere to complaint handling procedures, ensure qualified personnel, and follow written production and process control procedures. These issues led to the release of out-of-specification products and a systemic breakdown in quality assurance.