483
Prime Matter LabsPrime Matter Labs – FDA 483, Jul 13, 2026
Record Details
An FDA inspection of Prime Enterprises LLC, an OTC manufacturer in Hialeah, FL, revealed a significant issue regarding the identity testing of drug product components. The firm failed to perform complete identity testing on all incoming containers/lots of high-risk components, leading to the release of materials for manufacturing without adequate assurance of their identity or freedom from contamination. This lapse in quality control is a serious concern for drug product safety and efficacy.
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