FDA 483 - Avlon Industries, Inc - January 24, 2023

Avlon Industries, Inc., a drug product manufacturer in Melrose Park, IL, was cited for numerous significant deficiencies in its quality control unit, laboratory controls, and manufacturing processes. The inspection revealed a systemic lack of written procedures, validation, and testing, impacting product quality, identity, strength, and purity. These issues suggest a broad failure to adhere to good manufacturing practices.