FDA Inspection 709392 — Hyperbaric Technologies Inc.
The FDA completed an inspection of Hyperbaric Technologies Inc. on Feb 4, 2011 in Amsterdam, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Feb 4, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Amsterdam, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14714 | 21 CFR 820.30(c) | Design input - Lack of or inadequate procedures |
| 14715 | 21 CFR 820.30(d) | Design output - Lack of or inadequate procedures |
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |