FDA Inspection 1077303 — NEWCLIP TECHNICS SAS
The FDA completed an inspection of NEWCLIP TECHNICS SAS on Dec 6, 2018 in Haute-Goulaine. 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: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 6, 2018
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Haute-Goulaine (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |