Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-07.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Nov 2025 – 7 Nov 2025 | Human Drugs | 483 | On file |
| 28 Aug 2023 – 31 Aug 2023 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Aug 2023
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Marcellinus D Dordunoo
Investigators
FDA investigators tied to this site in the record.
Truong X Nguyen1 insp.
Marcellinus D Dordunoo1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Shanghai Aucyun Pharmaceuticals Co., Ltd's 2 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