FDA Inspection 1027504 — On Site Gas Systems Inc.
The FDA completed an inspection of On Site Gas Systems Inc. on October 3, 2017 in Newington, CT. 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
- October 3, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Newington, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |