FDA Inspection 1250170 — Erkul Kozmetik Sanayi Ve Ticaret A.S.
The FDA completed an inspection of Erkul Kozmetik Sanayi Ve Ticaret A.S. on Sep 27, 2024 in Avcilar. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 27, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Avcilar (Turkey)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1979 | 21 CFR 211.182 | Chronological Order of Equipment Log Entries |