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 3014937058.
Observations5
Issue DateSeptember 21, 2023
StatusNo Warning Letter
Establishment TypeDrug Manufacturer
Related Inspections2
Establishment Details
Firm
ModernaTX, Inc.
Location
Norwood, Massachusetts, United States
FEI Number
3014937058
Establishment Type
Drug Manufacturer
Product Type
Biologics
Issue Date
September 21, 2023
Country
United States
Inspection History, 2023 to 2024
NAI1
VAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated.