FDA Inspection 873734 — Cenorin, LLC
The FDA completed an inspection of Cenorin, LLC on May 2, 2014 in Kent, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 2, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Kent, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3147 | 21 CFR 820.170(a) | Lack of or inadequate instructions |
| 3323 | 21 CFR 820.170(b) | Installer records |
| 3696 | 21 CFR 820.100(b) | Documentation |