Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
1 Sep 2022
21 CFR 1.505(a)(2)
Evaluation - performance, risk
Cited by Steven B Chiu, Melody M Ragasa-Leong
1 Sep 2022
21 CFR 1.506(a)(1)
Approved supplier procedures - importer established
Cited by Steven B Chiu, Melody M Ragasa-Leong
1 Sep 2022
21 CFR 1.506(b)
Supplier verification - establish written procedures
Cited by Steven B Chiu, Melody M Ragasa-Leong
Inspected site
MHMARUKAI HAWAII CO LTDHonolulu, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1.504(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.505(a)(2) | 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 1.508(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 observations
The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere