Recalls & Safety Records

Warning letterFDA · Dec 19, 2017

Maine Natural Health, Inc. 12/19/17

Named company: Maine Natural Health, Inc.

During the inspection, our investigator found a number of violations of the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary…

Warning letterFDA · Dec 14, 2017

BrainAlert, LLC 12/14/17

Named company: BrainAlert, LLC

The inspection revealed serious violations of the Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, Title 21, Code of Federal…

Warning letterFDA · Dec 13, 2017

GnuPharma Corp. 12/13/17

Named company: GnuPharma Corp.

During the inspection, our investigators found violations of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation,…

Warning letterFDA · Dec 13, 2017

Dynamic Technical Formulations 12/13/17

Named company: Dynamic Technical Formulations

The inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for dietary supplements, found in Title 21 of the Code of Federal Regulations, Part 111 (21 CFR Part…

Warning letterFDA · Dec 11, 2017

Arco Globus Trading LLC 12/11/17

Named company: Arco Globus Trading LLC

Based on the review of your websites and other product labeling, we have determined that your firm causes the introduction of unapproved new drugs for sale in interstate commerce in violation of sections…

Warning letterFDA · Nov 30, 2017

TruVision Health LLC 11/30/17

Named company: TruVision Health LLC

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…

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