FDA Inspection 922023 — Hollywog LLC
The FDA completed an inspection of Hollywog LLC on Apr 17, 2015 in Hixson, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 17, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Hixson, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2602 | 21 CFR 820.30(d) | Design output - review and approval |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |