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 3000719749.
Observations8
Issue DateJuly 23, 2015
StatusNo Warning Letter
Establishment TypeBiotech API Manufacturer
Related Inspections10
Establishment Details
Firm
Biogen MA Inc.
Issued To
Biogen Idec Inc
Location
Research Triangle Park, North Carolina, United States
FEI Number
3000719749
Establishment Type
Biotech API Manufacturer
Product Type
Drugs
Issue Date
July 23, 2015
Country
United States
Inspection History, 2011 to 2024
NAI5
VAI5
NAI means No Action Indicated. VAI means Voluntary Action Indicated.