FDA Inspection
Diacor, IncDiacor, Inc – FDA Inspection, Jun 25, 2009
Record Details
This FDA Inspection record concerns Diacor, Inc, with an inspection on June 25, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Diacor, Inc
- Inspection Date
- June 25, 2009
- Product Type
- Devices
View Company Profile
ID · 669fbcfc-086b-4f2a-8481-9e8076b26e7f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 592352
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Diacor, Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 8, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 19, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 17, 2010 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for Diacor, Inc
- FDA Inspection 1024795 - 2017-09-08
- FDA Inspection 836648 - 2013-06-19
- FDA Inspection 671010 - 2010-06-17
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