Overview
- 8 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-09-20.
At a glance
Inspections
8
Form 483s
5
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Sep 2024 – 20 Sep 2024 | Human Drugs | Clean | |
| 11 Apr 2022 – 15 Apr 2022 | Human Drugs | 483 | On file |
| 28 Oct 2019 – 8 Nov 2019 | Human Drugs | 483 | On file |
| 4 Sep 2017 – 8 Sep 2017 | Human Drugs | WL | On file |
| 17 Mar 2014 – 20 Mar 2014 | Human Drugs | Clean | |
| 27 Oct 2011 | Not recorded | 483 | On file |
| 25 Jun 2010 | Not recorded | 483 | On file |
| 23 Aug 2007 | Not recorded | Clean |
Investigators
FDA investigators tied to this site in the record.
Linda Thai1 insp.
Teresa I Navas1 insp.
Margaret M Annes1 insp.
Sneha S Patel1 insp.
Milva E Melendez1 insp.
Angela E Glenn1 insp.
Douglas C Kovacs1 insp.
Yumi J Hiramine1 insp.
Luis A Dasta1 insp.
Full site report
Get the verbatim findings behind Kyowa Hakko Bio 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