David A. Brown, Owner
TruVision Health, LLC
12162 South Business Park Drive
Suite 114
Draper, UT 84790
Dear Mr. Brown:
On May 15, 22-25, 30-31, 2017, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 12162 South Business Park Drive, Suite 114, Draper, Utah. 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 Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that the products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Further, a review of the product labels collected during the inspection, and a review of your website at https://truvisionhealth.com/, identified serious violations of the Act and applicable regulations. You can find copies of the Act and pertinent regulations through links on FDA’s homepage at www.fda.gov.
Read about it here: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm590807.htm
