Atlas

FDA-Inspected Site

Daiichi Sankyo, Inc.

11 FDA inspections are on record for Daiichi Sankyo, Inc. in Basking Ridge, United States.

Clean· No action indicated

Basking Ridge, United States · Last updated July 9, 2026

Overview

  • 11 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-05-04.

At a glance

Inspections

11

Form 483s

4

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
24 Apr 2026 – 4 May 2026Human DrugsClean
28 Jul 2025 – 1 Aug 2025Human Drugs483View 483 →
17 Nov 2022 – 30 Nov 2022Human DrugsClean
11 Jul 2022 – 15 Jul 2022Human DrugsClean
6 Apr 2022 – 8 Apr 2022Human DrugsClean
24 Mar 2021 – 30 Mar 2021Human DrugsClean
2 Jan 2019 – 8 Jan 2019Human Drugs483View 483 →
15 May 2017 – 19 May 2017Human DrugsClean
4 Aug 2014 – 9 Sep 2014Human Drugs483View 483 →
4 Jan 2011Not recorded483On file
12 Aug 2010Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

1 Aug 2025
FDCA 505-1(f)(3)(A)

Failure to comply with REMS Elements to Assure Safe Use (ETASU) A

Cited by Namita Kothary, Mayar M Mussa

1 Aug 2025
FDCA 505-1(f)(4)

Failure to comply with REMS Implementation System

Cited by Namita Kothary, Mayar M Mussa

8 Jan 2019
21 CFR 312.50

General responsibilities of sponsors

Cited by Peter R Lenahan

9 Sep 2014
21 CFR 312.50

General responsibilities of sponsors

Cited by Jonee J Mearns

Investigators

FDA investigators tied to this site in the record.

Michael Serrano4 insp.
Peter R Lenahan2 insp.
Jay B Shah1 insp.
Namita Kothary1 insp.
Mayar M Mussa1 insp.
Yangmin Ning1 insp.
Tyanna N Hadley1 insp.
Jonee J Mearns1 insp.
Dorothy J Denes1 insp.
Justine Tomasso1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 312.50Cited across public-safe Form 483 observations2x
FDCA 505-1(f)(3)(A)Cited across public-safe Form 483 observations1x
FDCA 505-1(f)(4)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Daiichi Sankyo, Inc.'s 4 Form 483s

Source PDFs, verbatim observations, and 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