Packaging On Demand, Inc. – FDA 483, Oct 18, 2021

An FDA inspection of Packaging On Demand Inc. in San Clemente, CA, a drug manufacturer, revealed significant deficiencies across multiple quality system areas. The firm failed to ensure proper quality control unit review and approval before drug product release, did not adequately investigate out-of-specification results, and lacked annual product reviews. Additionally, issues were noted with component testing, laboratory record completeness, and electronic data integrity, including the absence of controls to prevent raw data deletion and a lack of data backup.