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•United States

ImClone Systems, LLC, Branchburg, NJ – FDA Inspections

Inspection records and compliance data for ImClone Systems, LLC in Branchburg, New Jersey. 11 FDA inspections on record (2 OAI), 2 Form 483s, last inspected July 27, 2023.

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Company Profile

This profile covers ImClone Systems, LLC based in Branchburg, New Jersey, United States.

FDA Inspection History

FDA inspections
11
OAI
2
VAI
2
NAI
6
Unclassified
1
Form 483s
2
Warning letters
0

First inspected October 3, 2008. Last inspected July 27, 2023.

FDA inspections (11)

DateResultFDA center(s)Insp. #
July 27, 2023Not classifiedHuman Drugs1217252
August 25, 2022VAIHuman Drugs · Drug Quality Assurance1178892
August 21, 2020OAIHuman Drugs · Drug Quality Assurance1128945
November 26, 2019OAIHuman Drugs · Drug Quality Assurance1111276
March 9, 2018VAIHuman Drugs · Drug Quality Assurance1043915
September 21, 2017NAIHuman Drugs · Drug Quality Assurance1029810
July 10, 2015NAIHuman Drugs · Drug Quality Assurance933959
November 13, 2013NAIHuman Drugs · Drug Quality Assurance856113
December 11, 2012NAIHuman Drugs · Drug Quality Assurance810161
September 28, 2011NAIHuman Drugs · Drug Quality Assurance747073
October 3, 2008NAIHuman Drugs · Drug Quality Assurance539843
FDA documents

Form 483s (5)

  • Form 483s · July 27, 2023
  • Form 483s · August 22, 2022
  • Form 483s · August 21, 2020
  • Form 483s · November 26, 2019
  • Form 483s · March 9, 2018

EIRs (2)

  • EIRs · September 21, 2017
  • EIRs · July 10, 2015
People (6)
Saleem A. Akhtar
Person
Michael R. Klapal
Person
Russell J. Glapion
Person
Victor M. Cruz
Person
Nailing Zhang
Person
Yan Wang
Person
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Company Information

Name

ImClone Systems, LLC

FEI Number

3002889358

Address

33 Imclone Dr, Branchburg, New Jersey 08876, United States

Country

United States

ID: ccde4edf-e0cb-4367-a935-725ce0bad4d3

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Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
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