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CLOSEOUT LETTER

Orphic Nutrition MARCS-CMS 612470 —

Product:
Dietary Supplements

Recipient:
Recipient Name
Mr. Philipp Triebel
Recipient Title
Managing Director
Orphic Nutrition

2443 Fillmore St, #380-7475
San Francisco, CA 94115
United States

Issuing Office:
Office of Human and Animal Food Operations –West Division 5

United States


Dear Mr. Triebel:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 612470 dated April 13, 2021. 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. 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/
Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations – West Division 5


CC: Ms. Barbara Radon, Head of Regulatory & Compliance
SellerX
Jägerstr. 41
Berlin 10117, Germany
barbara.radon@sellerx.com

 
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