FDA Inspection
Celltrion Inc.Celltrion Inc. – FDA Inspection, May 3, 2024
Record Details
This FDA Inspection record concerns Celltrion Inc., with an inspection on May 3, 2024, issued by the Center for Drug Evaluation and Research.
- Company
- Celltrion Inc.
- Inspection Date
- May 3, 2024
View Company Profile
ID · e427a948-24ab-4779-9b7a-cbcf8db5d4b9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1237995
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
FDA Citations
3- 21 CFR 312.50General responsibilities of sponsors
- 21 CFR 600.80(c)(1)(iii)Reporting Requirements - submission of reports
- 21 CFR 600.80(b)Review of Adverse Experiences - SOPs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Celltrion Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| January 14, 2025 | Not classified | Office of Inspections and Investigations | |
| 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 |
| August 28, 2018 | Not classified | Office of Inspections and Investigations |
Other documents for Celltrion Inc.
- FDA Inspection 1280404 - 2025-01-14
- FDA Inspection 1233221 - 2024-02-27
- FDA Inspection 1177098 - 2022-06-03
- FDA Inspection 1108245 - 2019-10-22
- FDA Inspection 1071604 - 2018-08-28
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