Overview
- 10 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-03-26.
At a glance
Inspections
10
Form 483s
9
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Mar 2024 – 26 Mar 2024 | Human Drugs | 483 | On file |
| 12 Jul 2021 – 20 Jul 2021 | Human Drugs | 483 | On file |
| 1 Apr 2019 – 10 Apr 2019 | Human Drugs | 483 | On file |
| 21 Jan 2019 – 25 Jan 2019 | Human Drugs | Clean | |
| 5 Nov 2018 – 13 Nov 2018 | Human Drugs | 483 | On file |
| 26 Feb 2018 – 6 Mar 2018 | Human Drugs | 483 | On file |
| 17 Oct 2016 – 27 Oct 2016 | Human Drugs | 483 | On file |
| 16 May 2016 – 20 May 2016 | Human Drugs | 483 | View 483 → |
| 3 Apr 2014 – 11 Apr 2014 | Human Drugs | 483 | View 483 → |
| 6 Jul 2012 | Not recorded | 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.
Christopher T Middendorf3 insp.
Eileen A Liu1 insp.
Roger F Zabinski1 insp.
Marijo B Kambere1 insp.
Brian J Ryan1 insp.
Peter E Baker1 insp.
Justin A Boyd1 insp.
Sandra A Hughes1 insp.
Toyin B Oladimeji1 insp.
Edmund F Mrak1 insp.
David J Gomes1 insp.
Jose R Hernandez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hisun Pharmaceutical (Hangzhou) Co., Ltd.'s 9 Form 483s
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