FDA Inspection
ImClone Systems, LLCImClone Systems, LLC – FDA Inspection, Aug 25, 2022
Record Details
This FDA Inspection record concerns ImClone Systems, LLC, with an inspection on August 25, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- ImClone Systems, LLC
- Inspection Date
- August 25, 2022
- Product Type
- Drugs
View Company Profile
ID · 4ca8d2a4-1cd8-4a23-a59b-461a86132b5e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1178892
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
Other FDA inspections of ImClone Systems, LLC
10| Date | Classification | Office | Project area |
|---|---|---|---|
| July 27, 2023 | Not classified | New Jersey District Office | |
| 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 |
| March 9, 2018 | VAI | 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 1128945 - 2020-08-21
- FDA Inspection 1111276 - 2019-11-26
- FDA Inspection 1043915 - 2018-03-09
- FDA Inspection 1029810 - 2017-09-21
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