Overview
- 16 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2014-12-29.
At a glance
Inspections
16
Form 483s
4
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Dec 2014 – 29 Dec 2014 | Animal Drugs & Feeds | 483 | View 483 → |
| 8 Dec 2014 – 12 Dec 2014 | Animal Drugs & Feeds | Clean | |
| 19 Aug 2013 – 23 Aug 2013 | Animal Drugs & Feeds | Clean | |
| 19 Nov 2012 | Not recorded | 483 | View 483 → |
| 9 Jan 2012 | Not recorded | Clean | |
| 7 Apr 2010 | Not recorded | Clean | |
| 21 Apr 2009 | Not recorded | 483 | View 483 → |
| 24 Jan 2008 | Not recorded | 483 | On file |
| 15 May 2007 | Not recorded | Clean | |
| 30 Dec 2005 | Not recorded | Clean | |
| 31 Aug 2005 | Not recorded | Clean | |
| 26 Jan 2004 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Dec 2014
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Robert J Ham, Brett R Havranek, Ashley A Mutawakkil
29 Dec 2014
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Robert J Ham, Brett R Havranek, Ashley A Mutawakkil
29 Dec 2014
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Robert J Ham, Brett R Havranek, Ashley A Mutawakkil
29 Dec 2014
21 CFR 211.165(d)
Acceptance criteria for sampling & testing
Cited by Robert J Ham, Brett R Havranek, Ashley A Mutawakkil
29 Dec 2014
21 CFR 211.180(e)
Records reviewed annually
Cited by Robert J Ham, Brett R Havranek, Ashley A Mutawakkil
Investigators
FDA investigators tied to this site in the record.
Victoria A Wagoner3 insp.
Robert J Ham2 insp.
Brett R Havranek2 insp.
Ashley A Mutawakkil2 insp.
Eric M Mueller2 insp.
Zachary A Bogorad1 insp.
Lori Gioia1 insp.
Cody D Rickman1 insp.
Kellia N Hicks1 insp.
Tamara J Umscheid1 insp.
Patricia L Payne1 insp.
Ralph H Vocque1 insp.
Danial S Hutchison1 insp.
Warren J Lopicka1 insp.
Patrick L Wisor1 insp.
Cynthia M Goudeau1 insp.
Gwyn G Dickinson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.44 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bayer Healthcare Animal Health Inc's 4 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