Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-19.
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 |
|---|---|---|---|
| 19 Mar 2025 | Foods & Cosmetics | Clean | |
| 13 Jul 2023 – 28 Jul 2023 | Foods & Cosmetics | 483 | View 483 → |
| 8 Sep 2022 – 25 Oct 2022 | Foods & Cosmetics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Jul 2023
21 CFR 1.506(a)(1)
Approved supplier procedures - importer established
Cited by Tracey T Duong
Investigators
FDA investigators tied to this site in the record.
Tracey T Duong2 insp.
Samuel A Francis1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1.504(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1.505(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1.506(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1.506(e)(1)(i)(B) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1.502(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Wooltari 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