Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-29.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Jun 2026 – 29 Jun 2026 | Foods & Cosmetics | 483 | On file |
| 18 Feb 2025 – 27 Feb 2025 | Foods & Cosmetics | 483 | View 483 → |
| 8 Sep 2023 | Foods & Cosmetics | Clean | |
| 15 May 2018 | Foods & Cosmetics | Clean | |
| 17 Jun 2013 | Foods & Cosmetics | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Feb 2025
21 CFR 1.504(d)
Document review entity's hazard analysis
Cited by Devina K Budhan, Devina K Amini
27 Feb 2025
21 CFR 1.506(a)(1)
Approved supplier procedures - importer established
Cited by Devina K Budhan, Devina K Amini
27 Feb 2025
21 CFR 1.506(b)
Supplier verification - establish written procedures
Cited by Devina K Budhan, Devina K Amini
27 Feb 2025
21 CFR 1.506(e)(1)
Verification activity before import, periodically
Cited by Devina K Budhan, Devina K Amini
Investigators
FDA investigators tied to this site in the record.
State Agency2 insp.
Wilmarie Marrero-Santiago1 insp.
Devina K Budhan1 insp.
Devina K Amini1 insp.
Devon O Seymour1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1.502(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.504(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.506(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.506(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.506(e)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Runoland USA, INC.'s 2 Form 483s
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