Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-11-05.
At a glance
Inspections
5
Form 483s
4
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Oct 2024 – 5 Nov 2024 | Human Drugs | 483 | On file |
| 24 Jun 2019 – 2 Jul 2019 | Human Drugs | 483 | On file |
| 9 Jan 2017 – 13 Jan 2017 | Human Drugs | 483 | On file |
| 10 Aug 2015 – 13 Aug 2015 | Medical Devices & Rad Health | Clean | |
| 23 Aug 2012 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Jose M Cayuela1 insp.
Joel D Hustedt1 insp.
Peter E Baker1 insp.
Marijo B Kambere1 insp.
Janete F Guardia1 insp.
Xiaojun Yan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind AMO (Hangzhou) Co., Ltd.'s 4 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