FDA Inspection
ImClone Systems, LLCImClone Systems, LLC – FDA Inspection, Nov 26, 2019
Record Details
This FDA Inspection record concerns ImClone Systems, LLC, with an inspection on November 26, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- ImClone Systems, LLC
- Inspection Date
- November 26, 2019
- Product Type
- Drugs
View Company Profile
ID · 0ee54811-983a-45a9-a6f3-43b7ec934dda
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1111276
- 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 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 |
| 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 1178892 - 2022-08-25
- FDA Inspection 1128945 - 2020-08-21
- FDA Inspection 1043915 - 2018-03-09
- FDA Inspection 1029810 - 2017-09-21
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