Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-11-08.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Oct 2019 – 8 Nov 2019 | Human Drugs | Clean | |
| 11 Sep 2017 – 15 Sep 2017 | Human Drugs | 483 | On file |
| 10 Mar 2014 – 14 Mar 2014 | Human Drugs | 483 | On file |
| 2 Jul 2010 | Not recorded | 483 | On file |
Investigators
FDA investigators tied to this site in the record.
Margaret M Annes1 insp.
Sneha S Patel1 insp.
Marcus F Yambot1 insp.
Angela E Glenn1 insp.
Yumi J Hiramine1 insp.
Luis A Dasta1 insp.
Full site report
Get the verbatim findings behind Kyowa Hakko Bio Co. Ltd.'s 3 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