FDA Inspection 1066879 — Hyperbaric Technologies Inc.
The FDA completed an inspection of Hyperbaric Technologies Inc. on Sep 26, 2018 in Amsterdam, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 26, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Amsterdam, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3159 | 21 CFR 820.184 | DHR content |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3696 | 21 CFR 820.100(b) | Documentation |