FDA 483 - Avantor Performance Materials LLC - April 14, 2021

Avantor Performance Materials LLC, a repacker in Paris, KY, received a Form FDA 483 with three observations. The inspection revealed significant deficiencies in equipment and utensil maintenance, inadequate record-keeping for maintenance activities, and a lack of proper secondary review for cleaning and maintenance logs. These issues indicate a failure to ensure the safety, identity, strength, quality, or purity of drug products.