FDA WARNING_LETTER - LEC Custom Products, Inc - March 06, 2020

On September 24, 2020, the FDA issued a Warning Letter to LEC Custom Products, Inc. following an inspection from March 2-6, 2020, at their Brampton, Ontario facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations included: 1. **Inadequate Equipment Design and Maintenance (21 CFR 211.63):** The firm's water system, a main component in non-sterile OTC drugs, had stagnant piping and consistently failed USP specifications for conductivity. The firm did not routinely test for microbial attributes, including *Burkholderia cepacia*. 2. **Lack of Process Validation (21 CFR 211.100(a)):** The firm lacked executed process validation for OTC products and the water system, despite prior commitments. 3. **Insufficient Cleaning Validation (21 CFR 211.67(a)):** No cleaning validation data was available for shared manufacturing and filling equipment, a repeat observation. 4. **Absence of Stability Testing Program (21 CFR 211.166(a)):** The firm lacked appropriate stability data to support product expiration dates, another repeat violation. 5.