Overview
- 6 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-12-03.
At a glance
Inspections
6
Form 483s
5
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Dec 2025 – 3 Dec 2025 | Medical Devices & Rad Health | WL | |
| 12 Nov 2025 – 21 Nov 2025 | Human Drugs | WL | On file |
| 16 Jan 2023 – 19 Jan 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Oct 2019 – 18 Oct 2019 | Human Drugs | 483 | View 483 → |
| 24 Oct 2016 – 2 Nov 2016 | Human Drugs | 483 | On file |
| 21 Apr 2014 – 25 Apr 2014 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Oct 2019
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Seneca D Toms, Jennifer M Gogley
18 Oct 2019
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Seneca D Toms, Jennifer M Gogley
18 Oct 2019
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Seneca D Toms, Jennifer M Gogley
18 Oct 2019
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Seneca D Toms, Jennifer M Gogley
Investigators
FDA investigators tied to this site in the record.
Sunita Pandey1 insp.
Eileen A Liu1 insp.
Steven A Brettler1 insp.
Melanie W Pishnery1 insp.
Seneca D Toms1 insp.
Jennifer M Gogley1 insp.
Kellia N Hicks1 insp.
Marissa S Steinhagen1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Huons Co., Ltd.'s 5 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