Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
Inspected site
FTFertility Technology Resources, Inc.Murphy, United States
Inspection team
PHPerry H Gambrell
Cited regulations
CFR citations associated with this Form 483.
| 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 483 report
Get the verbatim text of all 5 observations
Every observation in full, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere