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  5. Bio Focus Co. Ltd. - 12/15/2015
  1. Warning Letters


Bio Focus Co. Ltd.

Bio Focus Co. Ltd.

United States

Issuing Office:

United States


Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
 Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002

DEC 15 2015

Mr. Jeong Ku Seo
Bio Focus Co. Ltd
1202 Deahyun Technoworld
Uiwang-si 437-753
Korea, Republic of (South)

Dear Mr. Seo:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter [CMS #407508] dated August 26, 2013. 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 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 yours,


James L. Woods
Deputy Director
Patient Safety and Product Quality
Office of In Vitro Diagnostics and
   Radiological Health
Center for Devices and Radiological Health