FDA Inspection 1013990 — Cefimeca
The FDA completed an inspection of Cefimeca on April 26, 2017 in La Talaudiere. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 26, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- La Talaudiere (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |