FDA 483 - PLZ Corp - May 21, 2026

PLZ Corp, a contract manufacturer in Riverside, CA, was inspected and cited for significant deficiencies across its quality systems. Observations included inadequate monitoring and control of purified water systems, deficient pH meter calibration, failure to perform growth promotion testing on media, insufficient computer system controls allowing unauthorized file deletion, and widespread quality control unit failures related to document control, material release, change control, and stability chamber monitoring. The findings indicate a broad lack of adherence to cGMP requirements.