FDA 483 - Prime Packaging - August 01, 2025

An FDA inspection of PE Packaging, LLC dba Prime Packaging, an OTC repackager in Medley, FL, revealed significant deficiencies across its quality control unit, production processes, and facility controls. Observations included failures in annual product reviews, supplier qualification, validation reporting, complaint investigations, process validation, equipment qualification, temperature control, and environmental contamination prevention. These issues indicate a systemic lack of adherence to good manufacturing practices, posing risks to drug product identity, strength, purity, and quality.