Natco Pharma Limited – FDA Warning Letter, Oct 18, 2023

On April 8, 2024, the FDA issued a Warning Letter to Natco Pharma Limited following an inspection from October 9-18, 2023, at their Kothur Village, Telangana, India facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Inadequate Equipment Cleaning (21 CFR 211.67(a)):** Investigators observed residue with multiple active pharmaceutical ingredients (APIs) exceeding allowable limits in "cleaned" non-dedicated equipment (VS/034 and T/020). The firm's response, attributing residues to higher (b)(4) and claiming no contamination in certain tablets, was deemed inadequate. The FDA stated that testing of control samples and placebo batches did not scientifically prove products were free of contaminants, and the scope of the investigation was insufficient. The firm failed to address unknown peaks from swab samples. 2. **Inadequate Investigations (21 CFR 211.192):** The firm failed to thoroughly investigate unexplained discrepancies in finished product batches and components, concluding investigations without root cause determination or CAPA initiation. Questionable practices regarding CGMP record disposition and destruction were also noted. The firm's commitment to review investigations and hire a consultant was