FDA WARNING_LETTER - Neva Global Grup Sanayi Ic Ve Dis Ticaret Anonim Sirketi - September 20, 2024

On March 12, 2025, the FDA issued a Warning Letter to Neva Global Grup Sanayi Ic Ve Dis Ticaret Anonim Sirketi following an inspection from September 16-20, 2024. 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. **Failure to conduct identity testing for drug product components (21 CFR 211.84(d)(1) and 211.84(d)(2)):** The firm did not adequately test components, including active ingredients, and relied on supplier Certificates of Analysis (COA) without validation. Specifically, they failed to test incoming (b)(4) for (b)(4) contamination, a known lethal hazard. Their response, proposing HPLC acquisition, was deemed inadequate for lacking a detailed testing plan, supplier qualification, and retrospective assessment. 2. **Failure to establish adequate written procedures for production and process control (21 CFR 211.100(a)):** The firm lacked adequate validation of production processes and documentation for equipment qualification. Their response was insufficient, lacking supportive documentation and a retrospective impact assessment. 3. **Failure to establish an adequate written stability testing program (21 CFR 211