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Astellas Pharma Inc., Takahagi, Japan – FDA Inspections

Inspection records and compliance data for Astellas Pharma Inc. in Takahagi. 4 FDA inspections on record, 1 Form 483, last inspected June 06, 2025.

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Company Profile

This profile covers Astellas Pharma Inc. based in Takahagi, Japan.

FDA Inspection History

FDA inspections
4
OAI
0
VAI
1
NAI
2
Unclassified
1
Form 483s
1
Warning letters
0

First inspected October 15, 2009. Last inspected June 6, 2025.

FDA inspections (4)

DateResultFDA center(s)Insp. #
June 6, 2025Not classifiedHuman Drugs1274304
December 13, 2018NAIHuman Drugs · Drug Quality Assurance1076386
June 27, 2014NAIHuman Drugs · Drug Quality Assurance886634
October 15, 2009VAIHuman Drugs · Drug Quality Assurance633570
FDA documents

Form 483s (1)

  • Form 483s · June 6, 2025
People (2)
Jacob G. Lutz
Person
Nobuo Kasahara
Person
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Tianish Laboratories Private Limited
Medichem, S.A.
Zydus Lifesciences Limited
Matrix Pharmacorp Private Limited
Patheon Biologics B.V.
SpecGx LLC
Neuland Laboratories Limited (Unit I)
Company Information

Name

Astellas Pharma Inc.

FEI Number

3002808523

Address

160-2, Oazaakahama, Takahagi, Japan

Country

Japan

ID: 23dd5b22-f65a-44d8-ba32-8de91558f67f

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