Micro Labs Limited – FDA Warning Letter, May 13, 2014

On January 9, 2015, the FDA issued a Warning Letter to Micro Labs Limited following an inspection from May 5-13, 2014, at their Verna, India facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211) for finished pharmaceuticals, rendering their drug products adulterated under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. Additionally, violations of Section 505(k) of the Act and 21 CFR 314.81 regarding post-market reporting requirements were identified.

Key violations included: 1. **Incomplete Laboratory Records (21 CFR 211.194(a)):** The firm failed to include complete data from all tests in batch release decisions. Investigators found uninvestigated Out-of-Specification (OOS) data from unauthorized "trial" High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultra Violet (UV) spectroscopy, and (b)(4) analyses. These "trial" injections, often with obscured traceability, were not reviewed or considered, and some showed OOS results. 2. **Inadequate Computer System Controls (21 CFR 211.68(b)):** A lack of controls to prevent changes, substitution, or overwriting