Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-08-10.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Aug 2017 – 10 Aug 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Sep 2012 | Not recorded | Clean | |
| 16 Oct 2008 | Not recorded | 483 | On file |
| 16 Aug 2007 | Not recorded | Clean | |
| 19 Sep 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Aug 2017
21 CFR 820.160(a)
Lack of or inadequate procedures for distribution
Cited by Perry H Gambrell, Claudette D Brooks
10 Aug 2017
21 CFR 820.20(c)
Management review - defined interval, sufficient frequency
Cited by Perry H Gambrell, Claudette D Brooks
10 Aug 2017
21 CFR 820.22
Quality Audits - defined intervals
Cited by Perry H Gambrell, Claudette D Brooks
10 Aug 2017
21 CFR 820.50(a)(3)
Acceptable supplier records, inadequate records
Cited by Perry H Gambrell, Claudette D Brooks
Investigators
FDA investigators tied to this site in the record.
Perry H Gambrell1 insp.
Claudette D Brooks1 insp.
Babatunde D Babalola1 insp.
Paul W Moy1 insp.
Andrew W Gunn1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Fertility Technology Resources, Inc.'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