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  5. The Tender Corporation dba Adventure Ready Brand - 599789 - 09/28/2023
  1. Warning Letters

CLOSEOUT LETTER

The Tender Corporation dba Adventure Ready Brand MARCS-CMS 599789 —

Delivery Method:
ELECTRONIC DELIVERY/READ RECEIPT
Product:
Drugs
Recipient:
Recipient Name
Mr. Christopher Heye
Recipient Title
Chief Executive Officer
The Tender Corporation dba Adventure Ready Brand

994 Industrial Park Road
Littleton, NH 03561-3956
United States

cheye@adventurereadybrands.com
Issuing Office:
Division of Pharmaceutical Quality Operations I

United States

Dear Mr. Heye:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CMS #599789], dated July 23, 2020. Based on our evaluation, it appears that you have adequately addressed the violations contained in this Warning Letter.

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.


Respectfully,
/S/
Lisa Harlan
Acting Program Division Director
U.S. Food and Drug Administration
Office of Pharmaceutical Quality Operations
Division I

cc:
Mr. John Gaulin
Chief Operating Officer
The Tender Corporation dba Adventure Ready Brand 994 Industrial Park Road
Littleton, NH 03561 – 3956
jgaulin@adventurereadybrands.com

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