FDA Inspection 560769 — Safety Medical International, Inc.
The FDA completed an inspection of Safety Medical International, Inc. on Feb 6, 2009 in Apopka, 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). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 6, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Apopka, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2339 | 21 CFR 820.22 | Quality Audit/Reaudit - documentation |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3193 | 21 CFR 820.30(g) | Design validation - simulated testing |
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 3681 | 21 CFR 820.70(b) | Verification or validation of changes |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |