Asept Pak Inc. – FDA 483, Aug 4, 2023

Asept Pak Inc. in Malone, NY, a contract manufacturer of sterile products, received a Form FDA-483 citing two significant observations. The firm failed to adequately document corrective and preventive action activities, with multiple CAPA files remaining open past their due dates without proper extensions. Additionally, the inspection revealed a lack of documented periodic inspections and preventative maintenance for several critical equipment assets used in the aseptic filling process.