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CLOSEOUT LETTER

Sovereign Laboratories, LLC MARCS-CMS 606490 —

Product:
Food & Beverages
Recipient:
Recipient Name
Douglas Wyatt
Sovereign Laboratories, LLC

70 Sheath Dr
Sedona, AZ 86336
United States

Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

United States

Dear: Mr. Douglas Wyatt,

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our COVID-19 Warning Letter Re: 606490, issued June 15, 2020. Based on our evaluation, it appears you have addressed the violation(s) contained in the 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/
Carrie Lawlor
Branch Chief
Dietary Supplement and Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration

cc:
HFS-605
CMS # 606490/ WA# 331763
FEI# 3014751882

 
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