U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Celltrion Inc. - 534262 - 09/17/2018
  1. Warning Letters

CLOSEOUT LETTER

Celltrion Inc. MARCS-CMS 534262 —

Reference #:
FEI 3005241015
Product:
Drugs

Recipient:
Recipient Name
Woo Sung Kee
Recipient Title
Vice-Chairman / CEO
Celltrion Inc.

23 Academy-ro
Yeonsu-gu
Incheon
22014
South Korea

Issuing Office:
Center for Drug Evaluation and Research

United States


Dear Mr. Kee,

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-18-28 issued on January 26, 2018. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The FDA expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely,
/S/
Lixin (Leo) Xu, M.D., Ph.D.
Compliance Officer
Global Compliance Branch 2 (GCB2)
Division of Drug Quality I (DDQI)
Office of Manufacturing Quality (OMQ)
Office of Compliance (OC)
Center for Drug Evaluation and Research (CDER)