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CLOSEOUT LETTER

Takeda Pharmaceutical Company Limited MARCS-CMS 603596 —

Delivery Method:
Via Email
Reference #:
3004664162
Product:
Drugs
Recipient:
Recipient Name
Mr. Christophe Weber
Recipient Title
President and CEO
Takeda Pharmaceutical Company Limited

Tokyo Head Office
2-1-1, Nihonbashi-Honcho Chuo-ku
Tokyo
103-8668
Japan

Issuing Office:
Center for Drug Evaluation and Research | CDER

United States

Dear Mr. Weber:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-20-37 dated June 9, 2020.

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/
for Rafael Arroyo
Compliance Officer
Division of Drug Quality I

 
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