Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-09-22.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Aug 2023 – 22 Sep 2023 | Animal Drugs & Feeds | 483 | View 483 → |
| 18 Nov 2009 | Not recorded | 483 | View 483 → |
| 26 Aug 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Sep 2023
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Taichun Qin, Sara H Gabel, Julia N Alvarez
22 Sep 2023
21 CFR 211.165(a)
Testing and release for distribution
Cited by Taichun Qin, Sara H Gabel, Julia N Alvarez
22 Sep 2023
21 CFR 211.165(b)
Microbiological testing
Cited by Taichun Qin, Sara H Gabel, Julia N Alvarez
22 Sep 2023
21 CFR 211.166(a)
Lack of written stability program
Cited by Taichun Qin, Sara H Gabel, Julia N Alvarez
22 Sep 2023
21 CFR 211.192
No written record of investigation
Cited by Taichun Qin, Sara H Gabel, Julia N Alvarez
Investigators
FDA investigators tied to this site in the record.
Thomas W Gordon2 insp.
Taichun Qin1 insp.
Sara H Gabel1 insp.
Julia N Alvarez1 insp.
Estefania Fernandez1 insp.
Ligia M Sanders1 insp.
Steven M Galvez1 insp.
Joanne M Fukuda1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.150 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | 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(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(b) | 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(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 530.13(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 530.13(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 530.13(b)(4) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Precision Equine, LLC's 2 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