Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-01-10.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Jan 2020 – 10 Jan 2020 | Human Drugs | 483 | On file |
| 7 Jan 2019 – 12 Jan 2019 | Human Drugs | 483 | View 483 → |
| 4 Sep 2017 – 8 Sep 2017 | Human Drugs | 483 | On file |
| 12 Sep 2016 – 16 Sep 2016 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Lindsey S Fleischman1 insp.
Roger F Zabinski1 insp.
Cheryl A Clausen1 insp.
Anitha P Govada1 insp.
Shelby N Marler1 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 211.28(b) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Haimen Pharma Inc.'s 4 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