Overview
- 11 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-04-14.
At a glance
Inspections
11
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Apr 2023 – 14 Apr 2023 | Animal Drugs & Feeds | Clean | |
| 11 Jun 2019 – 17 Jun 2019 | Animal Drugs & Feeds | Clean | |
| 11 Aug 2016 – 12 Aug 2016 | Animal Drugs & Feeds | Clean | |
| 18 Sep 2013 – 23 Sep 2013 | Animal Drugs & Feeds | Clean | |
| 13 Apr 2011 | Not recorded | 483 | View 483 → |
| 18 Oct 2010 | Not recorded | 483 | View 483 → |
| 17 Feb 2010 | Not recorded | 483 | View 483 → |
| 19 Oct 2006 | Not recorded | Clean | |
| 10 Jun 2004 | Not recorded | Clean | |
| 17 Oct 2003 | Not recorded | Clean | |
| 1 Jun 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Apr 2011
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Amir A Abdalla, Lisa L Gilliam
13 Apr 2011
21 CFR 211.160(b)(4)
Establishment of calibration procedures
Cited by Amir A Abdalla, Lisa L Gilliam
18 Oct 2010
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Shirley J Berryman, Lisa L Gilliam, John T Vonderbrink
18 Oct 2010
21 CFR 211.100(a)
Changes to Procedures Not Reviewed, Approved
Cited by Shirley J Berryman, Lisa L Gilliam, John T Vonderbrink
18 Oct 2010
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Shirley J Berryman, Lisa L Gilliam, John T Vonderbrink
Investigators
FDA investigators tied to this site in the record.
Cody D Rickman2 insp.
Lisa L Gilliam2 insp.
Shirley J Berryman2 insp.
Jill J Tillman1 insp.
Gretchen L Trendel1 insp.
Michele L Obert1 insp.
Carl A Huffman1 insp.
Zachary A Bogorad1 insp.
Amir A Abdalla1 insp.
John T Vonderbrink1 insp.
Megan M Kirk1 insp.
Robin K Reel1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(c)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Ivy Animal Health, Inc.'s 3 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