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FDA Inspection
•Celltrion Inc.•August 28, 2018

Celltrion Inc. – FDA Inspection, Aug 28, 2018

Record Details

This FDA Inspection record concerns Celltrion Inc., with an inspection on August 28, 2018, issued by the Office of Inspections and Investigations, covering human drugs.

Company
Celltrion Inc.
Inspection Date
August 28, 2018
Product Type
Human Drugs
Office
Office of Inspections and Investigations
Person
  • Thuy T. Nguyen (FDA Associated Person)
View Company Profile

ID · 3d941692-3f0e-4112-87b6-0c5c353634ef

Inspection Facts

Inspection number
1071604
FDA center
Human Drugs
Outcome
Form 483 issued

Other FDA inspections of Celltrion Inc.

8
DateClassificationOfficeProject area
January 14, 2025Not classifiedOffice of Inspections and Investigations
May 3, 2024VAICenter for Drug Evaluation and ResearchPostmarket Surv. and Epidemiology
February 27, 2024VAIDrug Quality Assurance
June 3, 2022VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
October 22, 2019VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 8 other inspections on the company page
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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