Overview
- 7 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-04-14.
At a glance
Inspections
7
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Apr 2017 – 14 Apr 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 Sep 2013 – 25 Sep 2013 | Medical Devices & Rad Health | Clean | |
| 30 Mar 2011 | Not recorded | Clean | |
| 29 Aug 2008 | Not recorded | 483 | On file |
| 15 Nov 2006 | Not recorded | Clean | |
| 2 Sep 2004 | Not recorded | Clean | |
| 8 Nov 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Apr 2017
21 CFR 820.90(b)(1)
Procedures for product review,disposition lack of/inadequate
Cited by Miaja Umaedi
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.186 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(g)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Theragenics Corporation's 2 Form 483s
Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat