FDA 483 - PQ Corporation - February 22, 2022

PQ Corporation, a drug substance manufacturer in Utica, IL, received an FDA Form 483 with six observations. The inspection revealed significant deficiencies including a lack of an independent quality unit, untimely investigations, inadequate documentation for lot control, poor facility maintenance, and unvalidated computerized systems. These issues indicate a need for comprehensive improvements in the firm's quality assurance and control processes.