What happened
Original notice title
Valentine Enterprises, Inc. MARCS-CMS 705119, July 17, 2025
From the archived source record
Based on inspectional findings and review of the product documents collected during the inspection, we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Adulterated Dietary Supplements The inspection of your facility from October 8 through October 24, 2024, identified serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause the dietary supplement product, Vibrant Health Green Vibrance (“VH Green Vibrance”), manufactured at your facility to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)] because it has been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Your significant violations of the CGMP requirements are as follows: 1. Your firm failed to, for each dietary supplement that you manufacture, establish product specifications for the identity, purity, strength, composition and limits on contamination of the finished batch of the dietary supplement as required in 21 CFR 111.70(e). Your third-party laboratory said they did not determine the suitability of the following methods for testing VH Green Vibrance: BAM chapter 12 for testing for presence of S. aureus ; AOAC 991.14 for testing for presence of E. coli ; AOAC-RI 121501 for testing for the presence of Salmonella . Misbranded Dietary Supplements In addition, we reviewed your product labels collected during the inspection and have determined the MuscleTech EuphoriQ Pre-Workout Watermelon Candy, VH Green Vibrance, Vibrant Health Joint Vibrance, and Premium Green Superfood Cytogreens products you manufacture are misbranded under section 403 of the Act [21 U.S.C. 343] because they do not comply with the labeling requirements for dietary supplements. 1.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- d24516dbaa54
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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