Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-21.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Nov 2025 – 21 Nov 2025 | Human Drugs | 483 | On file |
| 4 Mar 2019 – 8 Mar 2019 | Human Drugs | Clean | |
| 24 Jul 2017 – 27 Jul 2017 | Human Drugs | Clean | |
| 13 Jun 2016 – 17 Jun 2016 | Human Drugs | WL | On file |
| 27 Oct 2011 | Not recorded | Clean | |
| 1 Mar 2007 | Not recorded | Clean |
Investigators
FDA investigators tied to this site in the record.
Victoria Spivak1 insp.
Truong X Nguyen1 insp.
Juan R Jimenez Garcia1 insp.
Justin A Boyd1 insp.
Shirley J Berryman1 insp.
Jeremy W Rotton1 insp.
Full site report
Get the verbatim findings behind Sekisui Medical Co., Ltd.'s 2 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