What happened
Original notice title
Spartan Enterprises Inc. dba Watershed Wellness Center MARCS-CMS 642030, March 08, 2023
From the archived source record
Based on inspectional findings and a review of your websites, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Unapproved New/Misbranded Drugs This is to advise you that the FDA reviewed your product labels following the inspection of your facility. In addition, taxanes appear to stimulate apoptosis, or programmed cell death, which is often inhibited in cancer cells.” o A video titled “Gingko Biloba Benefits” [an ingredient in Dr. Taxanes . . . prevent harmful cells from entering mitosis. 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). Bob’s Naturals Yew VeggieCaps, Gingko Magic, Milk Thistle Liver Support, Stone Breaker Capsules and Powder, and Magtein products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)]. Adulterated Dietary Supplements The inspection revealed 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 111). Bob’s Naturals Parasite Killer, and Raw Food World Sleep Deep Powder products are adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they were prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. You failed to establish specifications for each dietary supplement that you manufacture for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or lead to the adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e).
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
- 8d7c00be797d
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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