Lex Inc. – FDA Warning Letter, Feb 28, 2023

The FDA issued a Warning Letter to Lex Inc. following an inspection from February 13 to February 28, 2023, at their Medley, Florida drug manufacturing facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211), rendering their drug products adulterated.

Key violations include: 1. **Inadequate Quality Control Unit (QCU):** The QCU failed to ensure CGMP compliance and product specifications, lacking written procedures for roles, approval/rejection of components/products, review of records, and approval of procedures/specifications. The firm's response was deemed inadequate for not providing detailed CAPA, updated procedures, well-defined QU roles, or timelines. 2. **Failure to Test Components:** The firm failed to test incoming components for identity and validate supplier test analyses. Specifically, identity testing for glycerin and propylene glycol was insufficient, posing risks of contamination (e.g., DEG/EG). The firm's commitment to outsource testing and update procedures was inadequate as it didn't address the full scope, impact, or risks to distributed batches. 3. **Lack of Process Validation:** The firm lacked adequate written procedures for production and process control and an inclusive process validation program. Process performance qualification (PPQ) studies were incomplete, and the firm's response did not commit to completing prospective PP