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  5. Great Lakes Gelatin Company - 612323 - 11/05/2021
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CLOSEOUT LETTER

Great Lakes Gelatin Company MARCS-CMS 612323 —

Reference #:
FY21-HAFE6-03
Product:
Dietary Supplements
Recipient:
Recipient Name
James Burkett
Recipient Title
President
Great Lakes Gelatin Company

253 Commerce Dr.
Ste. 101
Grayslake, IL 60030
United States

JamesB@greatlakesgelatin.com
Issuing Office:
Office of Human and Animal Food Operations East-VI

United States

Dear Mr. Burkett,

The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter FY21-HAFE6-03. Based on our evaluation, it appears that you have addressed the violation(s) 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/
Kelli Wilkinson LCDR
Director of Compliance HAFE6 division

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