FDA Inspection
MicroSurgical Technology IncMicroSurgical Technology Inc – FDA Inspection, Jun 11, 2009
Record Details
This FDA Inspection record concerns MicroSurgical Technology Inc, with an inspection on June 11, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- MicroSurgical Technology Inc
- Inspection Date
- June 11, 2009
- Product Type
- Devices
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ID · a7c78713-2bd8-4611-9670-16de1452699e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 590062
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.100(a)(2)Investigation procedures
- 21 CFR 803.18(e)Results of evaluation not in mfr"s MDR file
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Other FDA inspections of MicroSurgical Technology Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 16, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 20, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 5, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for MicroSurgical Technology Inc
- FDA Inspection 946043 - 2015-10-16
- FDA Inspection 823207 - 2013-03-20
- FDA Inspection 725966 - 2011-05-05
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