Company
United StatesTheragenics Corporation, Buford, GA – FDA Inspections
Inspection records and compliance data for Theragenics Corporation in Buford, Georgia. 3 FDA inspections on record, 1 Form 483, last inspected April 14, 2017.
Company Profile
This profile covers Theragenics Corporation based in Buford, Georgia, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 0
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected March 30, 2011. Last inspected April 14, 2017.
Most cited issue areas
- Periodic equipment inspections1 inspection
- Procedures for product review,disposition lack of/inadequate1 inspection
- QSR1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 14, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1014170 |
| September 25, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 850629 |
| March 30, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 717182 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Theragenics Corporation
FEI Number
1037598
Address
5203 Bristol Industrial Way, Buford, Georgia 30518, United States
Country
United States
ID: d22d8217-48ed-4ae7-986c-7d26a4deeb5a