FDA Inspection 586534 — HydroCision, Inc.
The FDA completed an inspection of HydroCision, Inc. on May 8, 2009 in North Billerica, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 8, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- North Billerica, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2351 | 21 CFR 820.25(b) | Training |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |