FDA 483 - Product Packaging West, Inc. - July 18, 2023

Product Packaging West, Inc. in N Hollywood, CA, was inspected by the FDA from July 10-18, 2023, and received a Form 483 with five observations. The inspection revealed significant deficiencies in the firm's quality control unit, failure to investigate drug product sample deterioration, unvalidated equipment and cleaning procedures, and inadequate batch production and control records. These issues indicate a lack of adherence to current Good Manufacturing Practices for drug products.