FDA Inspection 735431 — Hydrofera, LLC
The FDA completed an inspection of Hydrofera, LLC on July 20, 2011 in Manchester, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 20, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Manchester, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |
| 537 | 21 CFR 820.70(a) | Production processes |