THERAGENICS CORP. FDA Inspection Record
THERAGENICS CORP. is an FDA-registered facility (FEI 1037598) located in BUFORD, GA, US. RegDataLab tracks 3 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Apr 14, 2017: Voluntary Action Indicated (VAI)
- Inspections on record
- 3 (1 VAI, 2 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 1, latest Oct 9, 2018
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 14, 2017 | Voluntary Action Indicated (VAI) | Periodic equipment inspections (21 CFR 820.70(g)(2)) QSR (21 CFR 820.186) Procedures for product review,disposition lack of/inadequate (21 CFR 820.90(b)(1)) |
| Sep 25, 2013 | No Action Indicated (NAI) | No citations listed |
| Mar 30, 2011 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Oct 9, 2018 | Class II | Z-0643-2019 | Theragenics Applicator Needle (18g x 20cm)
The device is comprised four basic elements… Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed |
Facility details
- Company
- Theragenics Corporation
- Location
- BUFORD, GA (US)
- Source
- device