Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-01-16.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Jan 2025 – 16 Jan 2025 | Human Drugs | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Jan 2025
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Daveta L Bailey, Cassidy W Criss
16 Jan 2025
21 CFR 211.110(c)
In-process materials characteristics testing
Cited by Daveta L Bailey, Cassidy W Criss
16 Jan 2025
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Daveta L Bailey, Cassidy W Criss
16 Jan 2025
21 CFR 211.134(a)
Correct labels during finishing operations
Cited by Daveta L Bailey, Cassidy W Criss
16 Jan 2025
21 CFR 211.192
No written record of investigation
Cited by Daveta L Bailey, Cassidy W Criss
Investigators
FDA investigators tied to this site in the record.
Daveta L Bailey1 insp.
Cassidy W Criss1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.134(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Horizon Tool Inc.'s 1 Form 483
Source PDFs 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