Overview
- 8 public-safe observations are available for this inspection.
- 4 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.
21 Apr 2017
21 CFR 111.570(b)(2)(i)
Record - person document; time of performance
Cited by Zachary A Bogorad, Haroon Vohra
21 Apr 2017
21 CFR 111.570(b)(2)(i)
Record - person document; time of performance
Cited by Zachary A Bogorad, Haroon Vohra
21 Apr 2017
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Zachary A Bogorad, Haroon Vohra
Inspected site
UHUSANA Health Sciences, Inc.West Valley City, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.570(b)(2)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 8 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