Overview
- 9 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-09-05.
At a glance
Inspections
9
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Aug 2024 – 5 Sep 2024 | Human Drugs | 483 | On file |
| 11 Nov 2019 – 15 Nov 2019 | Human Drugs | Clean | |
| 13 May 2019 – 17 May 2019 | Human Drugs | 483 | View 483 → |
| 5 Nov 2018 – 9 Nov 2018 | Human Drugs | Clean | |
| 11 Jun 2018 – 15 Jun 2018 | Human Drugs | 483 | View 483 → |
| 16 Oct 2017 – 20 Oct 2017 | Human Drugs | Clean | |
| 27 Jul 2017 – 2 Aug 2017 | Human Drugs | 483 | On file |
| 7 Sep 2015 – 18 Sep 2015 | Human Drugs | 483 | On file |
| 31 Mar 2014 – 3 Apr 2014 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
17 May 2019
21 CFR 211.110(b)
In-process conformity - examination, sample testing
Cited by Samina S Khan
Investigators
FDA investigators tied to this site in the record.
Christopher T Middendorf2 insp.
Marijo B Kambere2 insp.
Gam S Zamil1 insp.
Cynthia Jim1 insp.
Samina S Khan1 insp.
Camerson E Moore1 insp.
Xiaoping Guan1 insp.
Ademola O Daramola1 insp.
Ivis L Negron Torres1 insp.
Marie F Morin1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind CSPC Ouyi Pharmaceutical Co., Ltd.'s 6 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