FDA Inspection
Microgenics CorporationMicrogenics Corporation – FDA Inspection, Jun 14, 2012
Record Details
This FDA Inspection record concerns Microgenics Corporation, with an inspection on June 14, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Microgenics Corporation
- Inspection Date
- June 14, 2012
- Product Type
- Devices
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ID · c8248777-db4a-476c-bffb-f760c35661b0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 784645
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
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Other FDA inspections of Microgenics Corporation
9| Date | Classification | Office | Project area |
|---|---|---|---|
| August 17, 2018 | Not classified | San Francisco District Office | |
| December 15, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 16, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 20, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 25, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Microgenics Corporation
- FDA Inspection 1156794 - 2018-08-17
- FDA Inspection 998394 - 2016-12-15
- FDA Inspection 934731 - 2015-07-16
- FDA Inspection 899320 - 2014-10-20
- FDA Inspection 853150 - 2013-10-25
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