Overview
- 8 public-safe observations are available for this inspection.
- 4 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.
2 Nov 2015
21 CFR 110.35(a)
Buildings/sanitary
Cited by Tracy M Portelli, Valerie A Potopsingh, Tracy Portelli
2 Nov 2015
21 CFR 110.35(a)
Buildings/sanitary
Cited by Tracy M Portelli, Valerie A Potopsingh, Tracy Portelli
2 Nov 2015
21 CFR 110.35(b)(2)
Storage requirements
Cited by Tracy M Portelli, Valerie A Potopsingh, Tracy Portelli
2 Nov 2015
21 CFR 110.35(b)(2)
Storage requirements
Cited by Tracy M Portelli, Valerie A Potopsingh, Tracy Portelli
Inspected site
WGWholesale Gulluoglu, LLCAstoria, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.35(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.80(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.80(b)(7) | Cited across public-safe Form 483 observations | 2x |
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