483
PQ CorporationFDA 483 - PQ Corporation - February 22, 2022
Record Details
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.
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ID · b4a92c6a-fccb-4029-b49b-5d29746a0dd9