Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-03-15.
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 |
|---|---|---|---|
| 11 Mar 2024 – 15 Mar 2024 | Human Drugs | 483 | View 483 → |
| 23 May 2022 – 27 May 2022 | Human Drugs | WL | View 483 → |
| 27 Apr 2022 – 28 Apr 2022 | Foods & Cosmetics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
27 May 2022
21 CFR 211.125(a)
Strict control not exercised over labeling issued
Cited by Song Y Lavalais
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 111.205(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.70(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Kobayashi America Manufacturing, LLC's 3 Form 483s
Source PDFs and 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