FDA Inspection
Celltrion Inc.Celltrion Inc. – FDA Inspection, Oct 22, 2019
Record Details
This FDA Inspection record concerns Celltrion Inc., with an inspection on October 22, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Celltrion Inc.
- Inspection Date
- October 22, 2019
- Product Type
- Drugs
View Company Profile
ID · 31d22129-bbff-4836-8162-a11953f41efe
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1108245
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 211.42(c)(10)(iii)Air Supply
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 | |
| 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 |
| August 28, 2018 | Not classified | Office of Inspections and Investigations |
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 1071604 - 2018-08-28
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