FDA 483 - Tan-Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret A.S. - February 27, 2026
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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.
- Inspection Date
- February 27, 2026
- Product Type
- Drugs
ID · 41eacb4c-2f40-4fc4-9800-b5c784dfa09b