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 3002889358.
Observations2
Issue DateNovember 26, 2019
StatusNo Warning Letter
Establishment TypeBiological Drug Manufacturer
Related Inspections10
Establishment Details
Firm
ImClone Systems, LLC
Location
Branchburg, New Jersey, United States
FEI Number
3002889358
Establishment Type
Biological Drug Manufacturer
Product Type
Drugs
Issue Date
November 26, 2019
Country
United States
Inspection History, 2008 to 2022
NAI6
VAI2
OAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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