Overview
- 15 public-safe observations are available for this inspection.
- 15 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.
5 Oct 2016
21 CFR 110.10(b)(7)
Storage of personal items
Cited by Talmane J Fisher, Christian L Witkovskie
5 Oct 2016
21 CFR 110.35(b)(1)
Safe and adequate for use
Cited by Talmane J Fisher, Christian L Witkovskie
5 Oct 2016
21 CFR 110.35(c)
Lack of effective pest exclusion
Cited by Talmane J Fisher, Christian L Witkovskie
5 Oct 2016
21 CFR 110.35(d)(3)
Non-food-contact surfaces (S)
Cited by Talmane J Fisher, Christian L Witkovskie
Inspected site
VGValley Gem Inc. - Valley GemMarietta, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.10(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(d)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1250.30(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1250.82(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1250.82(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1250.87 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 15 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