FDA Inspection 1100424 — WatchChild, LLC
The FDA completed an inspection of WatchChild, LLC on Aug 23, 2019 in Cary, NC. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 6 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Aug 23, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: 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 |