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CLOSEOUT LETTER

NutraCore Health Products MARCS-CMS 542906 — Sep 11, 2018

NutraCore Health Products - 542906 - 09/11/2018

Product:
Drugs

Recipient:
Recipient Name
Mr. Chris Beekman
NutraCore Health Products
Nutracore Health Products

1207 Halapa Way

Trinity, FL 34638
United States

Issuing Office:

DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
SILVER SPRING, MD 20993
United States


Dear Mr. Beekman:


The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 542906, issued January 11, 2018. Based on our evaluation, it appears you have addressed the violations contained in the 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/
Carrie Lawlor
Branch Chief
Dietary Supplement and Labeling Assessment  Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition