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

Tan-Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret A.S., an OTC drug manufacturer in Cekmekoy, Istanbul, was cited for significant deficiencies across its quality system. Issues include inadequate laboratory controls for raw materials, a non-compliant stability testing program, and failures in in-process material testing. Additionally, the firm lacked proper environmental controls, followed deficient production procedures, and maintained incomplete batch records.