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Tosoh Bioscience Inc MARCS-CMS 505636 —

Delivery Method:
Via Email

Recipient Name
Yoshiyuki Shindo
Recipient Title
Tosoh Bioscience Inc

6000 Shoreline Ct. #101
South San Francisco, CA 94080
United States

Issuing Office:
Office of Medical Devices and Radiological Health Operations (Division 1)

United States

Dear Mr. Shindo:

The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter CIN 16-505636-19, dated August 5, 2016. 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 Agency 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.

You may direct any questions or comments regarding this letter to Amy Cramer at amy.cramer@fda.hhs.gov or at 732-390-3822.

Gina M. Brackett
Director Compliance Branch
Office of Medical Device & Radiological Health Operations
Division 1 East
Office of Regulatory Affairs
U.S. Food and Drug Administration

cc: Dave Wurtz, Director Quality & Compliance, dave.wurtz@tosoh.com

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