Overview
- 6 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-08-29.
At a glance
Inspections
6
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Aug 2024 | Foods & Cosmetics | 483 | On file |
| 14 Sep 2021 – 15 Sep 2021 | Foods & Cosmetics | 483 | View 483 → |
| 2 Mar 2018 – 19 Mar 2018 | Foods & Cosmetics | 483 | View 483 → |
| 3 May 2016 – 24 May 2016 | Foods & Cosmetics | 483 | View 483 → |
| 22 Jul 2013 – 26 Jul 2013 | Foods & Cosmetics | 483 | View 483 → |
| 21 Apr 2011 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Mar 2018
21 CFR 117.80(c)
Manufacturing, Processing, Packing, Holding - Controls
Cited by Michael R Dominick
Investigators
FDA investigators tied to this site in the record.
Sonia E Ortiz2 insp.
State Agency1 insp.
Lirissia Mccoy1 insp.
Isaac N Baah1 insp.
Michael R Dominick1 insp.
Amy Kim1 insp.
Valerie A Potopsingh1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.37(e)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 110.10(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.10(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.37(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.37(e)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.20(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1250.30(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1250.32(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1250.33(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.10(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(d)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1250.30(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind International Harvest Inc's 6 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