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  5. Center for New Medicine/Perfectly Healthy by Connealy MD - 605804 - 07/06/2020
  1. Warning Letters

CLOSEOUT LETTER

Center for New Medicine/Perfectly Healthy by Connealy MD MARCS-CMS 605804 —

Product:
Dietary Supplements
Drugs
Recipient:
Recipient Name
Dr. Leigh Erin Connealy
Center for New Medicine/Perfectly Healthy by Connealy MD

6 Hughes, Suite 100
Irvine, CA 92618
United States

Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

5001 Campus Drive
College Park, MD 20740
United States

Dear: Dr. Leigh Erin Connealy,

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our COVID-19 Warning Letter Re: 605804, issued May 13, 2020. Based on our evaluation, it appears you have addressed the violation(s) 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 J. Lawlor
Carrie Lawlor Branch Chief
Dietary Supplement and Labeling Assessment Branch Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition

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