FDA 483 - Trilogy Laboratories, LLC - August 27, 2019

An FDA inspection of Trilogy Laboratories, LLC in Fort Myers, FL, revealed numerous significant cGMP deficiencies. The firm lacks a functional quality control unit, adequate laboratory controls, and proper stability data to support drug product expiration dates. Additionally, manufacturing processes are unvalidated, and batch and master production records are incomplete or absent, indicating a systemic failure to ensure the quality and purity of their topical human drug products.