FDA Inspection 1083336 — On Site Gas Systems Inc.
The FDA completed an inspection of On Site Gas Systems Inc. on March 14, 2019 in Newington, CT. 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
- March 14, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Newington, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 21425 | 21 CFR 820.184(f) | DHR - UDI not included |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |