FDA Inspection
Diacor, IncDiacor, Inc – FDA Inspection, Sep 8, 2017
Record Details
This FDA Inspection record concerns Diacor, Inc, with an inspection on September 8, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b00ee590-6683-465b-aa92-c608f937809f
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1024795
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.184DHR content
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.40(b)Document change records, maintained.
- 21 CFR 820.70(i)Software validation for automated processes
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Diacor, Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| June 25, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Diacor, Inc
- FDA Inspection 836648 - 2013-06-19
- FDA Inspection 671010 - 2010-06-17
- FDA Inspection 592352 - 2009-06-25
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