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 3000209996.
Observations5
Issue DateFebruary 10, 2023
StatusNo Warning Letter
Establishment TypeHuman Drug Manufacturer
Related Inspections8
Establishment Details
Firm
AGC Biologics, Inc.
Location
Bothell, Washington, United States
FEI Number
3000209996
Establishment Type
Human Drug Manufacturer
Product Type
Drugs
Issue Date
February 10, 2023
Country
United States
Inspection History, 2009 to 2026
NAI4
VAI4
NAI means No Action Indicated. VAI means Voluntary Action Indicated.