FDA Inspection 1100424 — WatchChild, LLC
The FDA completed an inspection of WatchChild, LLC on August 23, 2019 in Cary, NC. 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
- August 23, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Cary, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3147 | 21 CFR 820.170(a) | Lack of or inadequate instructions |
| 3266 | 21 CFR 820.86 | Acceptance status |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3409 | 21 CFR 820.200(d) | Service reports |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |