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CLOSEOUT LETTER

Aegle Nutrition LLC MARCS-CMS 546966 —

Delivery Method:
VIA UPS and Electronic Mail
Product:
Dietary Supplements

Recipient:
Recipient Name
John Ramsey
Recipient Title
President
Aegle Nutrition LLC

1300 Hutton Drive
Suite 110
Carrollton, TX 75006
United States

Issuing Office:
Office of Human and Animal Food-West Div. 3

United States

214-253-5200

Dear Mr. Ramsey:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (CMS Case #: 546966) on July 6, 2018. 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.

Sincerely,

/S/

Dana M. Lewis

Compliance Officer

Office of Human and Animal Food-West Div. 3

 
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