FDA Inspection
ImClone Systems, LLCImClone Systems, LLC – FDA Inspection, Mar 9, 2018
Record Details
This FDA Inspection record concerns ImClone Systems, LLC, with an inspection on March 9, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Jose O. Hernandez (Company Rep)
- Yvesna C. Blaise (Issuing Officer)
View Company Profile
ID · 05c601b8-2c85-43f1-810b-91f6047f862c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1043915
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of ImClone Systems, LLC
10| Date | Classification | Office | Project area |
|---|---|---|---|
| July 27, 2023 | Not classified | New Jersey District Office | |
| August 25, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 21, 2020 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 26, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 21, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for ImClone Systems, LLC
- FDA Inspection 1217252 - 2023-07-27
- FDA Inspection 1178892 - 2022-08-25
- FDA Inspection 1128945 - 2020-08-21
- FDA Inspection 1111276 - 2019-11-26
- FDA Inspection 1029810 - 2017-09-21
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