Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-07-17.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Jul 2024 | Foods & Cosmetics | Clean | |
| 8 Nov 2018 – 9 Nov 2018 | Foods & Cosmetics | 483 | View 483 → |
| 23 Nov 2015 – 25 Nov 2015 | Foods & Cosmetics | 483 | On file |
| 15 Jun 2012 | Not recorded | 483 | View 483 → |
| 4 Mar 2010 | Not recorded | WL | View 483 → |
| 26 Jun 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Jun 2012
21 CFR 110.20(b)(7)
Screening
Cited by Cathryn M Groehnert, Mario A Iglesias, Patrick R Dimapindan
15 Jun 2012
21 CFR 110.35(a)
Cleaning and sanitizing operations
Cited by Cathryn M Groehnert, Mario A Iglesias, Patrick R Dimapindan
15 Jun 2012
21 CFR 110.35(b)(1)
Safe and adequate for use
Cited by Cathryn M Groehnert, Mario A Iglesias, Patrick R Dimapindan
15 Jun 2012
21 CFR 110.35(c)
Lack of effective pest exclusion
Cited by Cathryn M Groehnert, Mario A Iglesias, Patrick R Dimapindan
Investigators
FDA investigators tied to this site in the record.
Cathryn M Groehnert2 insp.
Angelica Ornelas1 insp.
Emily D Lam1 insp.
Kevin Lee1 insp.
Comyar Shoghi1 insp.
Mario A Iglesias1 insp.
Patrick R Dimapindan1 insp.
Dennis N Hoang1 insp.
Jessica L Andrade1 insp.
Elizabeth M Dahl1 insp.
Cntrctmntr Nepsa1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.20(b)(7) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.35(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.35(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.40(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.20(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(d)(1) | 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 110.80(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Shah Distributors, Inc.'s 4 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