Acella Pharmaceuticals, LLC – FDA 483, Feb 10, 2023

Acella Pharmaceuticals, LLC, an Own Label Distributor in Alpharetta, GA, was cited with four observations, including repeat findings, during an FDA inspection. The firm demonstrated significant deficiencies in its quality control unit's responsibilities for drug product release and validation, inadequate laboratory controls for stability testing, and failures in thoroughly investigating discrepancies and handling product complaints. These issues indicate a lack of adherence to good manufacturing practices for drug products.