Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-07-21.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Jul 2023 – 21 Jul 2023 | Human Drugs | 483 | View 483 → |
| 9 Nov 2020 – 16 Nov 2020 | Human Drugs | 483 | On file |
| 24 Jun 2019 – 28 Jun 2019 | Human Drugs | 483 | On file |
| 25 Jun 2018 – 29 Jun 2018 | Human Drugs | Clean | |
| 3 Jan 2017 – 6 Jan 2017 | Human Drugs | Clean | |
| 20 Jun 2016 – 24 Jun 2016 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Jul 2023
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Timothy H Vo, Kevin P Regan
21 Jul 2023
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Timothy H Vo, Kevin P Regan
Investigators
FDA investigators tied to this site in the record.
Timothy H Vo1 insp.
Kevin P Regan1 insp.
Marijo B Kambere1 insp.
Marcus A Ray1 insp.
Camerson E Moore1 insp.
Christopher T Middendorf1 insp.
Zhigang Sun1 insp.
Theresa Kirkham1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Yichang Humanwell Oral Solid Dosage Plant's 3 Form 483s
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