FDA Inspection 553737 — RICA Surgical Products, Inc.
The FDA completed an inspection of RICA Surgical Products, Inc. on Dec 16, 2008 in Schiller Park, IL. 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
- Dec 16, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Schiller Park, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2269 | 21 CFR 820.20(a) | Quality policy and objectives |
| 2293 | 21 CFR 820.20(d) | Quality plan |
| 3167 | 21 CFR 820.198(a) | Complete files maintained |
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |