Overview
- 14 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-07-24.
At a glance
Inspections
14
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Jul 2024 – 24 Jul 2024 | Foods & Cosmetics | 483 | On file |
| 14 Dec 2021 – 16 Dec 2021 | Foods & Cosmetics | 483 | View 483 → |
| 22 Jan 2020 – 24 Jan 2020 | Foods & Cosmetics | 483 | View 483 → |
| 1 Mar 2017 – 8 Mar 2017 | Foods & Cosmetics | 483 | View 483 → |
| 17 Dec 2013 – 18 Dec 2013 | Foods & Cosmetics | 483 | View 483 → |
| 23 Nov 2011 | Not recorded | 483 | View 483 → |
| 29 Nov 2010 | Not recorded | 483 | View 483 → |
| 26 Mar 2008 | Not recorded | Clean | |
| 16 Aug 2006 | Not recorded | Clean | |
| 17 Aug 2005 | Not recorded | Clean | |
| 15 Mar 2004 | Not recorded | Clean | |
| 18 Nov 2003 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Jan 2020
21 CFR 117.35(a)
Sanitary Operations - Plant Maintenance
Cited by Frank J Koch, Elise L Mcdevitt
24 Jan 2020
21 CFR 123.6(c)(6)
Verification procedures - none/frequency
Cited by Frank J Koch, Elise L Mcdevitt
Investigators
FDA investigators tied to this site in the record.
John P Shelton3 insp.
State Agency1 insp.
Frank J Koch1 insp.
Elise L Mcdevitt1 insp.
Osama A Khatib1 insp.
David M Lamoureux1 insp.
Mark E Farrell1 insp.
Ashley M Whitehurst1 insp.
Teddy Tom1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 123.11(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 123.6(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 123.6(c)(6) | Cited across public-safe Form 483 observations | 3x |
| 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 123.12(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.8(a)(3)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.9(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind James Hook & Company, LLC's 7 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