FDA Inspection
Midmark CorporationMidmark Corporation – FDA Inspection, Jun 28, 2012
Record Details
This FDA Inspection record concerns Midmark Corporation, with an inspection on June 28, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Midmark Corporation
- Inspection Date
- June 28, 2012
- Product Type
- Devices
View Company Profile
ID · c0c7dff8-aa5f-4702-a930-e754445c437e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 790449
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
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Other FDA inspections of Midmark Corporation
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 15, 2019 | Not classified | Cincinnati District Office | |
| April 2, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 9, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 9, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 12, 2011 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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