Warning letterFDA · Jan 11, 2018
Named company: Healthy Healing dba Crystal Star
In addition, the Federal Trade Commission has reviewed your marketing claims for “Withdrawal Support” for potential violations of Sections 5 and 12 of the FTC Act, 15 U.S.C. §§ 45(a) and 52. A drug is…
Warning letterFDA · Jan 5, 2018
Named company: Coenzyme A, Inc. dba Coenzyme-A Technologies, Inc.
Examples of some of the claims that provide evidence that your product is intended for use as a drug include: From the article titled “Coenzyme-A TM ‘The Master Coenzyme TM ’” (available on your website):…
Warning letterFDA · Dec 19, 2017
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
Named company: Eden’s Answers Inc. and Sprigs Life Inc.
Based on the inspection, a review of the product labels collected during the inspection, and a review of your website at www.sprigslife.com, we have identified serious violations of the Federal Food, Drug, and…
Warning letterFDA · Dec 14, 2017
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
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
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
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…
Import alertFDA · Dec 8, 2017
Named company: TianXiang Liu
"Detention Without Physical Examination of Unapproved Human Growth Hormone (HGH)". Firm/address: TianXiang Liu Date Published : 12/08/2017 NO 624 2013 Wenhua , Chuangkr Garden , Shenzhen, GD CHINA
Warning letterFDA · Nov 30, 2017
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…