FDA Inspection 1035238 — Zyno Medical LLC
The FDA completed an inspection of Zyno Medical LLC on December 15, 2017 in Natick, MA. 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
- December 15, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Natick, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14717 | 21 CFR 820.30(g) | Design validation - software validation documentation |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |