Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-02-09.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Feb 2024 – 9 Feb 2024 | Human Drugs | Clean | |
| 7 Sep 2017 – 8 Sep 2017 | Human Drugs | Clean | |
| 27 Feb 2014 – 4 Mar 2014 | Human Drugs | 483 | View 483 → |
| 18 Aug 2009 | Not recorded | 483 | View 483 → |
| 25 Aug 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Mar 2014
21 CFR 211.84(c)(2)
Containers sampled so as to prevent contamination
Cited by James M Mason
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 211.125(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(c)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind HK Kolmar USA, LLC's 2 Form 483s
Verbatim observations 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