# FDA 483 - Tan-Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret A.S. - February 27, 2026

Source: https://www.keypedia.com/records/483/tan-alize-kozmetik-ve-temizlik-urunleri-sanayi-ve-ticaret-as/41eacb4c-2f40-4fc4-9800-b5c784dfa09b

> FDA 483 for Tan-Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret A.S. on February 27, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tan-Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret A.S.
- Inspection Date: 2026-02-27
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Tan-Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret A.S., an OTC drug manufacturer in Cekmekoy, Istanbul, revealed significant deficiencies across multiple areas. The firm failed to ensure proper laboratory controls, adhere to its stability testing program, and adequately test in-process materials. Additionally, issues were noted with microbiological control, air filtration systems, and the documentation of production and process control records.

## Related Documents

- [483 - 2026-02-27](https://www.keypedia.com/records/483/tan-alize-kozmetik-ve-temizlik-urunleri-sanayi-ve-ticaret-as/e047e55c-1eb6-403c-b81a-555cbbcdd218)

## Related Officers

- [Saleem A. Akhtar](https://www.keypedia.com/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)

Company: https://www.keypedia.com/companies/tan-alize-kozmetik-ve-temizlik-urunleri-sanayi-ve-ticaret-as/b0ea9992-a858-442a-94ca-dff1e31438f0

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8