FDA 483 - Allied Pharmacy Products. Inc. - January 10, 2023

An FDA inspection of Allied Pharmacy Products, Inc. in Delray Beach, FL, a specification developer, identified two significant issues. The firm failed to adequately document corrective and preventive action activities for an investigation and lacked established procedures for design transfer to a contract manufacturer. These observations indicate deficiencies in the firm's quality system regarding CAPA and design control.