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  5. Alternative Laboratories - 586947 - 05/21/2020
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CLOSEOUT LETTER

Alternative Laboratories MARCS-CMS 586947 —

Delivery Method:
VIA Electronic Mail
Reference #:
20-HAFE4-WLCOL-10
Product:
Dietary Supplements

Recipient:
Recipient Name
Mr. Kevin J. Thomas
Recipient Title
CEO
Alternative Laboratories

2231 Linwood Avenue
Naples, FL 34112-4737
United States

kevin@alternativelabs.com
Issuing Office:
Office of Human and Animal Food Operations Division IV East

United States

(787) 729-8500

Dear Mr. Thomas:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 19-HAFE4-WL-10 dated September 18, 2019. 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.

Kind regards,
/S/
Edwin Ramos
Director of Compliance Branch
OHAFO, Division IV East

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