FDA Inspection 1306922 — Tan-Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret A.S.
The FDA completed an inspection of Tan-Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret A.S. on February 27, 2026 in Cekmekoy. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 27, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cekmekoy (Turkey)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3548 | 21 CFR 211.46(c) | Air filtration system lacking in production area |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3607 | 21 CFR 211.160(b)(2) | Acceptance of in-process materials |