FDA Inspection 632590 — Hyperbaric America LLC
The FDA completed an inspection of Hyperbaric America LLC on December 2, 2009 in Lake Worth, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 2, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Lake Worth, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 2470 | 21 CFR 820.30(c) | Design input procedures - appropriateness |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3157 | 21 CFR 820.181(c) | DMR QA procedures and specifications |
| 3164 | 21 CFR 820.184(d) | Acceptance records |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |