FDA Inspection
Roscoe Medical IncRoscoe Medical Inc – FDA Inspection, Oct 26, 2012
Record Details
This FDA Inspection record concerns Roscoe Medical Inc, with an inspection on October 26, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Roscoe Medical Inc
- Inspection Date
- October 26, 2012
- Product Type
- Devices
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ID · e8d2790f-551a-48bd-9c2f-17c6443c94c3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 805110
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
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Other FDA inspections of Roscoe Medical Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 28, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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