Overview
- 4 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-02-12.
At a glance
Inspections
4
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Feb 2025 – 12 Feb 2025 | Foods & Cosmetics | Clean | |
| 20 Aug 2024 – 21 Aug 2024 | Animal Drugs & Feeds | Clean | |
| 6 Jul 2021 – 20 Jul 2021 | Animal Drugs & Feeds | Clean | |
| 13 Jan 2020 – 17 Jan 2020 | Animal Drugs & Feeds | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Jan 2020
21 CFR 507.33(a)
Hazard Analysis
Cited by Joshua C Schafer, Sidney M Smith, Robert P Neligan, Justin N Henson, Amanda K Willey, Phares O Okelo
17 Jan 2020
21 CFR 507.34(a)(1)
Preventive Controls
Cited by Joshua C Schafer, Sidney M Smith, Robert P Neligan, Justin N Henson, Amanda K Willey, Phares O Okelo
Investigators
FDA investigators tied to this site in the record.
Sidney M Smith3 insp.
Tanya L Keigley1 insp.
Joshua C Schafer1 insp.
Robert P Neligan1 insp.
Justin N Henson1 insp.
Amanda K Willey1 insp.
Phares O Okelo1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 507.33(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 507.34(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Gateway America LLC's 1 Form 483
Source PDFs 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