FDA Inspection 871352 — HydroCision, Inc.
The FDA completed an inspection of HydroCision, Inc. on April 16, 2014 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 16, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- North Billerica, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |