FDA 483 - Avion Pharmaceuticals, LLC - November 08, 2023

Avion Pharmaceuticals, LLC in Alpharetta, GA, was inspected and received a Form 483 with four observations. The inspection revealed significant deficiencies in process validation for drug products, inadequate quality control unit procedures including review of CMO records and supplier qualification, and failures in thoroughly reviewing discrepancies and investigations. Additionally, the firm lacked established procedures for handling returned drug products.