FDA Inspection 733222 — Hurricane Medical, Inc.
The FDA completed an inspection of Hurricane Medical, Inc. on Jul 5, 2011 in Bradenton, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 5, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bradenton, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3372 | 21 CFR 820.198(d) | Records of MDR Investigation |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |