Overview
- 6 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-12-14.
At a glance
Inspections
6
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Nov 2022 – 14 Dec 2022 | Human Drugs | 483 | On file |
| 24 Aug 2021 – 30 Aug 2021 | Human Drugs | 483 | On file |
| 12 Aug 2021 – 13 Aug 2021 | Human Drugs | Clean | |
| 25 Sep 2019 – 4 Oct 2019 | Human Drugs | 483 | On file |
| 3 Dec 2018 – 11 Dec 2018 | Human Drugs | 483 | On file |
| 11 Dec 2017 – 21 Dec 2017 | Human Drugs | 483 | On file |
Investigators
FDA investigators tied to this site in the record.
Cynthia Jim1 insp.
Lindsey S Fleischman1 insp.
Zhong Li1 insp.
Jacek Cieslak1 insp.
Michael Shanks1 insp.
Madushini N Dharmasena1 insp.
Dennis Cantellops Paite1 insp.
Scott R Nichols1 insp.
Thuy T Nguyen1 insp.
Full site report
Get the verbatim findings behind Kyowa Kirin Co., Ltd.'s 5 Form 483s
The full inspection record, as Atlas holds it, 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