Packaging On Demand, Inc. – FDA 483, Sep 27, 2024

The FDA inspected Packaging On Demand, Inc. in San Clemente, CA, a contract OTC drug manufacturer, revealing significant deficiencies across multiple systems. The firm failed to perform adequate identification testing of active ingredients, maintain proper reserve samples, and ensure appropriate equipment qualification and cleaning validation. Additionally, issues were noted with process validation, component sampling, and inventory control, indicating a lack of robust quality oversight for their OTC drug products.