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  5. Biotek, Inc. - 539361 - 07/08/2020
  1. Warning Letters

CLOSEOUT LETTER

Biotek, Inc. MARCS-CMS 539361 —

Product:
Dietary Supplements

Recipient:
Recipient Name
Norman J. Larsen
Recipient Title
President
Biotek, Inc.

334 Marshall Way N
Suite F
Layton, UT 84041
United States

Issuing Office:
Office of Human and Animal Foods Division IV West

United States


Dear Mr. Larsen:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, reference # HAF4W (DEN)-18-04-WL, issued March 13, 2018. Based on our evaluation, it appears that you have addressed the violation(s) contained in the referenced 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.

Sincerely,
/S/
LaTonya M. Mitchell, Ph.D.
Denver District Director
Program Division Director
Office of Human and Animal Foods
Division IV West

 
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