FDA Inspection
Innovatech Medical Resources L.P.Innovatech Medical Resources L.P. – FDA Inspection, Oct 7, 2011
Record Details
This FDA Inspection record concerns Innovatech Medical Resources L.P., with an inspection on October 7, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 7, 2011
- Product Type
- Devices
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ID · f2603ffc-019a-45cc-95ec-16771596fba4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 747446
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.140Lack of or inadequate procedures for handling
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
Showing 10 of 11 citations.
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Other FDA inspections of Innovatech Medical Resources L.P.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 13, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Innovatech Medical Resources L.P.
- FDA Inspection 799192 - 2012-09-13
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