Overview
- 14 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-04.
At a glance
Inspections
14
Form 483s
8
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Nov 2025 – 4 Nov 2025 | Human Drugs | 483 | View 483 → |
| 12 Jul 2021 – 23 Jul 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 Jun 2021 – 3 Jun 2021 | Human Drugs | 483 | On file |
| 28 Mar 2018 – 5 Apr 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 26 Jun 2015 – 2 Jul 2015 | Medical Devices & Rad Health | Clean | |
| 8 Jun 2015 – 11 Jun 2015 | Human Drugs | 483 | View 483 → |
| 15 Jun 2012 | Not recorded | Clean | |
| 30 Dec 2011 | Not recorded | 483 | On file |
| 6 May 2010 | Not recorded | Clean | |
| 11 Mar 2010 | Not recorded | 483 | View 483 → |
| 27 Aug 2008 | Not recorded | 483 | On file |
| 13 Feb 2006 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Nov 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Justin A Boyd, Tyler M Peterson
4 Nov 2025
21 CFR 211.68(b)
Computer control of master formula records
Cited by Justin A Boyd, Tyler M Peterson
23 Jul 2021
21 CFR 58.120(b)
Protocol: approval of changes
Cited by Nicole C Victoria, Eric S Myskowski
23 Jul 2021
21 CFR 58.185(a)(13)
Final report: storage locations
Cited by Nicole C Victoria, Eric S Myskowski
Investigators
FDA investigators tied to this site in the record.
Denise L Burosh3 insp.
Justin A Boyd2 insp.
Sandra A Hughes2 insp.
Tyler M Peterson1 insp.
Nicole C Victoria1 insp.
Eric S Myskowski1 insp.
Carl A Huffman1 insp.
Gregory R Brinsley1 insp.
Scott B Laufenberg1 insp.
Jacob W Reynolds1 insp.
Joel D Hustedt1 insp.
Charles Cote1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 58.35(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 58.63(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 58.29(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.35(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.120(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.185(a)(13) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.31(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.31(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.61 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Geneva Laboratories, Inc'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