FDA Inspection
Scimedx CorporationScimedx Corporation – FDA Inspection, Jan 22, 2010
Record Details
This FDA Inspection record concerns Scimedx Corporation, with an inspection on January 22, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Scimedx Corporation
- Inspection Date
- January 22, 2010
- Product Type
- Devices
View Company Profile
ID · e6c0a6aa-6117-4cc8-8231-27b349026fde
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 640388
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.72(b)(2)Calibration documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Scimedx Corporation
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 5, 2018 | Not classified | New Jersey District Office | |
| November 16, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 30, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Scimedx Corporation
- FDA Inspection 1116869 - 2018-10-05
- FDA Inspection 994636 - 2016-11-16
- FDA Inspection 808267 - 2012-11-30
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