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  5. NatureLab Corp. - 625768 - 04/25/2023
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NatureLab Corp. MARCS-CMS 625768 —

Delivery Method:
UPS Overnight
Dietary Supplements

Recipient Name
Charles B. Shea
Recipient Title
NatureLab Corp.

1606 Vantage Dr.
Carrollton, TX 75006-5613
United States

Issuing Office:
Division of Pharmaceutical Quality Operations II

United States

Dear Mr. Shea,

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated July 12, 2022, issued following inspection of your facility located at 1606 Vantage Dr., Carrollton, TX 75006-5613. 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. If you choose to reestablish or sell your operations, 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.

Jessica E. Havranek
Director of Compliance
Office of Human and Animal Food, WD3

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