Overview
- 6 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-07-18.
At a glance
Inspections
6
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Jul 2025 – 18 Jul 2025 | Human Drugs | 483 | View 483 → |
| 15 Oct 2018 – 19 Oct 2018 | Human Drugs | Clean | |
| 6 Jun 2017 – 9 Jun 2017 | Human Drugs | Clean | |
| 12 May 2014 – 15 May 2014 | Human Drugs | Clean | |
| 20 Sep 2012 | Not recorded | Clean | |
| 29 Jan 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Joseph A Piechocki1 insp.
Anastasia M Shields1 insp.
Yumi J Hiramine1 insp.
Bogdan Kurtyka1 insp.
Stephen J Mottola1 insp.
Jose R Hernandez1 insp.
Pal S Mayasandra1 insp.
Mark R Mcclain1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | 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 Daiichi Sankyo Europe GmbH's 1 Form 483
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