Overview
- 9 public-safe observations are available for this inspection.
- 9 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.
8 Nov 2013
21 CFR 110.10(b)(3)
Not washed/sanitized when appropriate
Cited by Christopher D Snyder, Jason R Caballero, Kathleen J Close
8 Nov 2013
21 CFR 110.10(b)(5)
Glove condition
Cited by Christopher D Snyder, Jason R Caballero, Kathleen J Close
8 Nov 2013
21 CFR 110.10(b)(7)
Storage of personal items
Cited by Christopher D Snyder, Jason R Caballero, Kathleen J Close
8 Nov 2013
21 CFR 110.10(b)(9)
Precautions against contamination--micro, foreign substances
Cited by Christopher D Snyder, Jason R Caballero, Kathleen J Close
8 Nov 2013
21 CFR 110.20(a)(1)
Harborage areas
Cited by Christopher D Snyder, Jason R Caballero, Kathleen J Close
Inspected site
VUVendors Unlimited CorporationDubuque, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.10(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(d)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(7) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 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