Overview
- 9 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-06-27.
At a glance
Inspections
9
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Jun 2019 – 27 Jun 2019 | Foods & Cosmetics | 483 | View 483 → |
| 26 Jul 2016 – 28 Jul 2016 | Foods & Cosmetics | 483 | On file |
| 18 Jun 2013 – 21 Jun 2013 | Foods & Cosmetics | Clean | |
| 23 Apr 2010 | Not recorded | 483 | View 483 → |
| 10 Jul 2008 | Not recorded | Clean | |
| 2 Jun 2006 | Not recorded | Clean | |
| 9 Jul 2003 | Not recorded | Clean | |
| 22 Mar 2001 | Not recorded | Clean | |
| 5 May 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Jun 2019
21 CFR 117.35(a)
Sanitary Operations - Plant Maintenance
Cited by Lynn L Wong, Stuart Kim, Jeremiah T Ulu
Investigators
FDA investigators tied to this site in the record.
Stuart Kim2 insp.
Lynn L Wong1 insp.
Jeremiah T Ulu1 insp.
Katherine M Taylor1 insp.
John Cook1 insp.
Melody M Ragasa Leong1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.93 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.12(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.12(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind H & K Inc's 3 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