FDA Inspection 1256366 — Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. Ve Tic. A.S.
The FDA completed an inspection of Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. Ve Tic. A.S. on Dec 12, 2024 in Esenyurt. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 12, 2024
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Esenyurt (Turkey)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |