Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2021-04-28.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 31 Mar 2021 – 28 Apr 2021 | Foods & Cosmetics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Apr 2021
21 CFR 1.504(d)
Document review entity's hazard analysis
Cited by Jeannie Pradyanata, Arnold C Shih
28 Apr 2021
21 CFR 1.505(a)(2)
Evaluation - performance, risk
Cited by Jeannie Pradyanata, Arnold C Shih
28 Apr 2021
21 CFR 1.506(a)(1)
Approved supplier procedures - importer established
Cited by Jeannie Pradyanata, Arnold C Shih
28 Apr 2021
21 CFR 1.506(b)
Supplier verification - establish written procedures
Cited by Jeannie Pradyanata, Arnold C Shih
28 Apr 2021
21 CFR 1.506(e)(3)
Verification activity review, assess
Cited by Jeannie Pradyanata, Arnold C Shih
Investigators
FDA investigators tied to this site in the record.
Jeannie Pradyanata1 insp.
Arnold C Shih1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1.504(d) | 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 1.506(e)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Kowa Trading Co's 1 Form 483
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