FDA Inspection
Celltrion Inc.Celltrion Inc. – FDA Inspection, Jun 2, 2017
Record Details
This FDA Inspection record concerns Celltrion Inc., with an inspection on June 2, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 30983a3a-f527-4b2f-b901-47287f8403d4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1013498
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Celltrion Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| January 14, 2025 | Not classified | Office of Inspections and Investigations | |
| May 3, 2024 | VAI | Center for Drug Evaluation and Research | Postmarket Surv. and Epidemiology |
| February 27, 2024 | VAI | Drug Quality Assurance | |
| June 3, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 22, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Celltrion Inc.
- FDA Inspection 1280404 - 2025-01-14
- FDA Inspection 1237995 - 2024-05-03
- FDA Inspection 1233221 - 2024-02-27
- FDA Inspection 1177098 - 2022-06-03
- FDA Inspection 1108245 - 2019-10-22
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