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•United States

Eisai, Inc. - Inspection Records

Inspection records and compliance data for Eisai, Inc. in Nutley, New Jersey. 7 FDA inspections on record, last inspected May 02, 2025.

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Company Profile

This profile covers Eisai, Inc. based in Nutley, New Jersey, United States.

FDA Inspection History

FDA inspections
7
OAI
0
VAI
3
NAI
4
Form 483s
0
Warning letters
0

First inspected September 27, 2010. Last inspected May 2, 2025.

Most cited issue areas

  • Changes to Procedures Not Reviewed, Approved1 inspection
  • Ensuring compliance with plan and protocol1 inspection
  • General responsibilities of sponsors1 inspection

FDA inspections (7)

DateResultFDA center(s)Insp. #
May 2, 2025NAIHuman Drugs · Bioresearch Monitoring1271039
February 9, 2023NAIHuman Drugs · Bioresearch Monitoring1198163
February 16, 2018VAIHuman Drugs · Bioresearch Monitoring1041308
December 9, 2015VAIHuman Drugs · Bioresearch Monitoring965277
April 20, 2015NAIHuman Drugs · Bioresearch Monitoring922940
January 17, 2013VAIHuman Drugs · Bioresearch Monitoring813538
September 27, 2010NAIHuman Drugs · Bioresearch Monitoring683663
FDA documents

Form 483s (1)

  • Form 483s · February 16, 2018
Related Companies

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Company Information

Name

Eisai, Inc.

FEI Number

3009413786

Address

200 Metro Blvd, Nutley, New Jersey 07110, United States

Country

United States

ID: 081df088-ce18-4702-a2b3-cb4e48ebe3e4

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