Overview
- 18 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-20.
At a glance
Inspections
18
Form 483s
8
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Mar 2025 – 20 Mar 2025 | Human Drugs | 483 | View 483 → |
| 13 Jun 2022 – 17 Jun 2022 | Human Drugs | 483 | View 483 → |
| 23 Sep 2019 – 27 Sep 2019 | Animal Drugs & Feeds | 483 | View 483 → |
| 12 Dec 2016 – 16 Dec 2016 | Human Drugs | 483 | View 483 → |
| 30 Jun 2015 – 7 Jul 2015 | Human Drugs | Clean | |
| 30 Nov 2012 | Not recorded | 483 | View 483 → |
| 9 Mar 2012 | Not recorded | 483 | View 483 → |
| 17 Aug 2011 | Not recorded | Clean | |
| 12 Mar 2010 | Not recorded | 483 | On file |
| 10 Feb 2010 | Not recorded | 483 | View 483 → |
| 1 May 2009 | Not recorded | Clean | |
| 16 Mar 2007 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Mar 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Erik W Koester, Christian F Gomez Lugo, Ifechimere I Okafor
20 Mar 2025
21 CFR 211.42(c)(10)(i)
Floors, walls, ceiling surfaces
Cited by Erik W Koester, Christian F Gomez Lugo, Ifechimere I Okafor
20 Mar 2025
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Erik W Koester, Christian F Gomez Lugo, Ifechimere I Okafor
20 Mar 2025
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Erik W Koester, Christian F Gomez Lugo, Ifechimere I Okafor
20 Mar 2025
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Erik W Koester, Christian F Gomez Lugo, Ifechimere I Okafor
Investigators
FDA investigators tied to this site in the record.
Kenneth G Klobus3 insp.
Sony Mathews2 insp.
George C Amedro2 insp.
Erik W Koester1 insp.
Christian F Gomez Lugo1 insp.
Ifechimere I Okafor1 insp.
Syeda N Mahazabin1 insp.
Juliana M Badalucco1 insp.
Anastasia M Shields1 insp.
Junho Pak1 insp.
Sasha M Latonis1 insp.
Alice S Tsao1 insp.
Paul C Mouris1 insp.
Bruce G Cooper1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(7) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind GC Hanford Manufacturing Company's 8 Form 483s
Source PDFs, 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