Recalls & Safety Records

Warning letterFDA · May 1, 2017

Thor Inc. 5/1/17

Named company: Thor Inc.

The inspection revealed serious violations of FDA’s Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal…

Warning letterFDA · Apr 17, 2017

The Vitamin C Foundation 4/17/17

Named company: The Vitamin C Foundation

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, World’s Finest Vitamin C Powder, Cardio-C, True…

Warning letterFDA · Apr 17, 2017

Sunstone, Inc. 4/17/17

Named company: Sunstone, Inc.

Unapproved New Drugs and Misbranded Drugs Based on the labeling claims on your website, your marketed products, Essiac Tea, Premium Organic, 8 oz., and Virxcan-X Salve, are drugs under section 201(g)(1) of the…

Warning letterFDA · Apr 14, 2017

Genetic Edge Compounds LLC 4/14/17

Named company: Genetic Edge Compounds LLC

During the inspection, our investigator found a number of violations of the current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements…

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