FDA Inspection
Theragenics CorporationTheragenics Corporation – FDA Inspection, Apr 14, 2017
Record Details
This FDA Inspection record concerns Theragenics Corporation, with an inspection on April 14, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 1751bc66-bb75-4919-9b7e-65b24b70eda4
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1014170
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.186QSR
- 21 CFR 820.70(g)(2)Periodic equipment inspections
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
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Other FDA inspections of Theragenics Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 25, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 30, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Theragenics Corporation
- FDA Inspection 850629 - 2013-09-25
- FDA Inspection 717182 - 2011-03-30
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