# FDA WARNING_LETTER - Tan Alize Kozmetik Ve Temizlik Urunleri - August 08, 2023

Source: https://www.keypedia.com/records/warning_letter/tan-alize-kozmetik-ve-temizlik-urunleri/c1f5c203-e0d4-423c-a19a-a3dd6bd6923f

> FDA WARNING_LETTER for Tan Alize Kozmetik Ve Temizlik Urunleri on August 08, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Tan Alize Kozmetik Ve Temizlik Urunleri
- Inspection Date: 2023-08-08
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Tan Alize Kosmetik, a Turkish manufacturer of OTC drug products, following a review of records submitted per Section 704(a)(4) of the FD&C Act. The letter, dated August 3, 2023, identifies significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include:
1.  **Failure to conduct identity testing for components (21 CFR 211.84(d)(1)):** The firm did not adequately test each shipment of high-risk components like glycerin for diethylene glycol (DEG) or ethylene glycol (EG) contamination using USP identification tests. This poses a significant safety risk due to the lethal poisoning incidents associated with DEG/EG.
2.  **Failure to establish an adequate quality control unit (21 CFR 211.22(a)):** The Quality Unit (QU) did not effectively oversee drug manufacturing operations, specifically failing to approve or reject components in the Materials System. Concerns were raised about the QU's oversight across other CGMP operations.

The FDA recommends engaging a qualified CGMP consultant to evaluate operations and assist in meeting requirements, including a comprehensive six-system audit. The firm was placed on Import Alert 66-40 on June 23, 2023. Corrective actions are required within 30 working days, and failure to

## Related Officers

- [Director](https://www.keypedia.com/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)

Company: https://www.keypedia.com/companies/tan-alize-kozmetik-ve-temizlik-urunleri/3190e24c-a117-4bdd-ae9e-80567ec42f7a

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