FDA Inspection
RICA Surgical Products, Inc.RICA Surgical Products, Inc. – FDA Inspection, Dec 16, 2008
Record Details
This FDA Inspection record concerns RICA Surgical Products, Inc., with an inspection on December 16, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- RICA Surgical Products, Inc.
- Inspection Date
- December 16, 2008
- Product Type
- Devices
View Company Profile
ID · 5b392f81-848b-49e7-9801-796a84d35573
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 553737
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.198(a)Complete files maintained
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.40(a)Document review, approval documentation
- 21 CFR 820.20(a)Quality policy and objectives
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Other FDA inspections of RICA Surgical Products, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 2, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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