FDA Inspection 1171546 — Sterlab
The FDA completed an inspection of Sterlab on Jun 10, 2022 in Vallauris. 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
- Jun 10, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Project Evaluation: Devices
- Location
- Vallauris (France)
Additional Details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |