Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
12 Aug 2010
21 CFR 111.75(a)(1)(i)
Component - verify identity, dietary ingredient
Cited by Adrian Rodriguez, Trina K Vick
12 Aug 2010
21 CFR 111.365(a)
Conditions, controls -protect; microorganisms, contamination
Cited by Adrian Rodriguez, Trina K Vick
12 Aug 2010
21 CFR 111.553
Written procedures - product complaint
Cited by Adrian Rodriguez, Trina K Vick
12 Aug 2010
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Adrian Rodriguez, Trina K Vick
Inspected site
ULUnited Laboratories Manufacturing, LLCCarrollton, United States
Inspection team
ARAdrian Rodriguez
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.365(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | 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(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
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