Overview
- 10 public-safe observations are available for this inspection.
- 10 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.
13 Aug 2009
21 CFR 110.93
Storage/transportation of finished goods (contamination)
Cited by Brandi L Garbutt, Maureen A Wentzel
13 Aug 2009
21 CFR 111.12(b)
Personnel - quality control operations; responsibilities
Cited by Brandi L Garbutt, Maureen A Wentzel
13 Aug 2009
21 CFR 111.16
Written procedures - pest control
Cited by Brandi L Garbutt, Maureen A Wentzel
Inspected site
UNUnited Nutrition Labs IncReedsville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.93 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.12(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.140(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.15(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.15(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.16 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 10 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