Company
United StatesImClone 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.
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)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 27, 2023 | Not classified | Human Drugs | 1217252 |
| August 25, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1178892 |
| August 21, 2020 | OAI | Human Drugs · Drug Quality Assurance | 1128945 |
| November 26, 2019 | OAI | Human Drugs · Drug Quality Assurance | 1111276 |
| March 9, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1043915 |
| September 21, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1029810 |
| July 10, 2015 | NAI | Human Drugs · Drug Quality Assurance | 933959 |
| November 13, 2013 | NAI | Human Drugs · Drug Quality Assurance | 856113 |
| December 11, 2012 | NAI | Human Drugs · Drug Quality Assurance | 810161 |
| September 28, 2011 | NAI | Human Drugs · Drug Quality Assurance | 747073 |
| October 3, 2008 | NAI | Human Drugs · Drug Quality Assurance | 539843 |
FDA documents
People (6)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
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