FDA Inspection 952742 — Misonix, Inc.
The FDA completed an inspection of Misonix, Inc. on December 14, 2015 in Farmingdale, NY. 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
- December 14, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Farmingdale, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |