Center for New Medicine/Perfectly Healthy by Connealy MD

CLOSEOUT LETTER Center for New Medicine/Perfectly Healthy by Connealy MD MARCS-CMS 605804 — July 06, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 07/10/2020 Regulated Product(s) Dietary Supplements Drugs