FDA 483 - I3 PHARMACEUTICALS LLC - May 22, 2026

I 3 Pharmaceuticals, LLC in Warminster, PA, was cited for two observations during an FDA inspection from May 18-22, 2026. The firm failed to properly design and maintain equipment, including an unqualified modification to a packaging line, and lacked written procedures for its use. Additionally, the quality control unit did not follow its own procedures, leading to delayed investigations of out-of-limit microbiological results and the release of affected drug product without proper review.