FDA Inspection 1026734 — Serf
The FDA completed an inspection of Serf on September 21, 2017 in Decines-Charpieu. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 21, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Decines-Charpieu (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 3696 | 21 CFR 820.100(b) | Documentation |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |