Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-12.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Sep 2025 – 12 Sep 2025 | Human Drugs | 483 | On file |
| 19 Sep 2023 – 21 Sep 2023 | Human Drugs | WL | View 483 → |
| 29 May 2013 | Human Drugs | Clean | |
| 26 Jan 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Sep 2023
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Torrey M Ward
21 Sep 2023
21 CFR 211.186(b)(9)
Complete instructions, procedures, specifications et. al.
Cited by Torrey M Ward
Investigators
FDA investigators tied to this site in the record.
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 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Higley Industries, Inc.'s 2 Form 483s
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