FDA Inspection 1150487 — Hobbs Medical, Inc.
The FDA completed an inspection of Hobbs Medical, Inc. on August 27, 2021 in Stafford Springs, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 27, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Stafford Springs, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 537 | 21 CFR 820.70(a) | Production processes |