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

Source: https://www.globalkeysolutions.net/records/warning_letter/neva-global-grup-sanayi-ic-ve-dis-ticaret-anonim-sirketi/b912474a-6a4f-4090-936a-b9bafadce6ad

> FDA WARNING_LETTER for Neva Global Grup Sanayi Ic Ve Dis Ticaret Anonim Sirketi on September 20, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Neva Global Grup Sanayi Ic Ve Dis Ticaret Anonim Sirketi
- Inspection Date: 2024-09-20
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)
- [Mehmet Akif Tutuncu](https://www.globalkeysolutions.net/people/mehmet-akif-tutuncu/1c5c9b60-27ef-45d0-9652-ee4cd38110a2)

Company: https://www.globalkeysolutions.net/companies/neva-global-grup-sanayi-ic-ve-dis-ticaret-anonim-sirketi/4c821d74-bd77-44b8-8756-e11ed1536058

Office: https://www.globalkeysolutions.net/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c