FDA Inspection
Medical Specialty Innovations, Inc.Medical Specialty Innovations, Inc. – FDA Inspection, Feb 13, 2017
Record Details
This FDA Inspection record concerns Medical Specialty Innovations, Inc., with an inspection on February 13, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 42c31bd4-e94a-4f3e-819f-172da1b33892
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1001735
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
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Other FDA inspections of Medical Specialty Innovations, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 9, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 18, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medical Specialty Innovations, Inc.
- FDA Inspection 850605 - 2013-09-09
- FDA Inspection 715492 - 2011-03-18
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