Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
2 Aug 2017
21 CFR 212.71(b)
Documentation of Non-Conforming Product Investigation
Cited by Hala L Selby
Inspected site
UOUniversity of Texas Southwestern Medical Center, TheDallas, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 212.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.60(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.60(g)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.71(b) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 5 observations
The source PDF, 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