Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3002807001.
Observations3
Issue DateJune 06, 2025
StatusNo Warning Letter
Establishment TypeSterile Drug Manufacturer
Related Inspections6
Establishment Details
Firm
Astellas Pharma Inc.
Location
Takaoka, -, Japan
FEI Number
3002807001
Establishment Type
Sterile Drug Manufacturer
Product Type
Drugs
Issue Date
June 06, 2025
Country
Japan
Inspection History, 2008 to 2025
NAI1
VAI5
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
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