Overview
- 17 public-safe observations are available for this inspection.
- 17 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
26 Oct 2010
21 CFR 111.12
Personnel - quality control personnel - qualified
Cited by Maureen A Wentzel, Maria A Reed, Seth J Goldenberg
26 Oct 2010
21 CFR 111.20(c)(2)
Physical plant - material review and disposition
Cited by Maureen A Wentzel, Maria A Reed, Seth J Goldenberg
26 Oct 2010
21 CFR 111.25(a)
Procedures - calibrating instruments
Cited by Maureen A Wentzel, Maria A Reed, Seth J Goldenberg
26 Oct 2010
21 CFR 111.27(a)(2)
Equipment - design - no contamination
Cited by Maureen A Wentzel, Maria A Reed, Seth J Goldenberg
26 Oct 2010
21 CFR 111.27(d)
Equipment - maintain, clean, sanitize
Cited by Maureen A Wentzel, Maria A Reed, Seth J Goldenberg
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 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.105(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.12 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.120(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.353 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.415(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.65 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.83(b)(4) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 17 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