FDA Inspection 658195 — Medical Devices, Inc.
The FDA completed an inspection of Medical Devices, Inc. on Apr 19, 2010 in Clearwater, 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
- Apr 19, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Clearwater, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3198 | 21 CFR 820.40(b) | Document changes, review and approval, communication |
| 3268 | 21 CFR 820.80(b) | Incoming inspection, testing, verification |
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 4060 | 21 CFR 820.20(b)(3)(i) | Management representative implementing the quality system |
| 4189 | 21 CFR 820.198(a) | General |