Lannett Company LLC – FDA 483, Aug 21, 2026

Lannett Company LLC, a drug manufacturer in Seymour, IN, was cited for significant deficiencies across its quality control unit, investigation processes, complaint handling, and facility maintenance. Issues included inadequate OOS investigations, failure to thoroughly review batch discrepancies, insufficient drug complaint investigations, and widespread pest infestation and water intrusion due to poor building repair and ineffective corrective actions. The findings indicate a systemic breakdown in GMP compliance.