Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-11-02.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 31 Oct 2023 – 2 Nov 2023 | Foods & Cosmetics | 483 | View 483 → |
| 29 Aug 2022 – 1 Sep 2022 | Foods & Cosmetics | 483 | View 483 → |
| 12 Jul 2021 – 21 Jul 2021 | Foods & Cosmetics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Nov 2023
21 CFR 1.506(e)(1)
Verification activity before import, periodically
Cited by Jeannie Pradyanata
1 Sep 2022
21 CFR 1.505(a)(2)
Evaluation - performance, risk
Cited by Steven B Chiu, Melody M Ragasa-Leong
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1.504(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1.505(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1.502(a) | 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 |
| 21 CFR 1.508(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind MARUKAI HAWAII CO LTD's 3 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