Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-08-22.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Aug 2018 | Foods & Cosmetics | Clean | |
| 27 Oct 2015 – 2 Nov 2015 | Foods & Cosmetics | 483 | View 483 → |
| 30 Jul 2013 – 2 Aug 2013 | Foods & Cosmetics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
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
Investigators
FDA investigators tied to this site in the record.
State Agency1 insp.
Tracy M Portelli1 insp.
Valerie A Potopsingh1 insp.
Tracy Portelli1 insp.
Sonia E Ortiz1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| 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 |
| 21 CFR 110.37(e)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1250.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1250.33(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1250.33(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1250.33(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1250.34 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Wholesale Gulluoglu, LLC's 2 Form 483s
Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat