What happened
Original notice title
VitaPurity Corporation 5/12/17
From the archived source record
We found serious violations of the Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your dietary supplement products Ellagic Ultra, Buffered Vitamin C Crystals, Coral Calcium with D3, Miracle Mushroom Blend, Lycopene 25 with Tomato Powder, Citral from Lemon Grass, and Pacific Ocean Shark Cartilage 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 dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Based on our review, we have concluded that your products identified below are in violation of sections 502(f)(1) and/or 505(a) of the Act [21 U.S.C. §§ 352(f)(1) and/or 355(a)]. Unapproved New Drugs/Misbranded Drugs The FDA reviewed your website [see original source] in April 2017 and determined that you take orders there for the products Ellagic Ultra, Buffered Vitamin C Crystals, Coral Calcium with D3, Miracle Mushroom Blend, Lycopene 25 with Tomato Powder, Citral from Lemon Grass, and Pacific Ocean Shark Cartilage. Pharmacokinet., 24(2): 183-9. • Khanduja, K.L., et al., 1999. Pregnancy-induced high blood pressure is a serious complication that can put both mother and child at risk.” • “Additional calcium intake may actually lower your risk for kidney stones.” Your website also includes disease claims in the form of citations to scientific publications. For example: • Bucher, H.C., et al., Effect of Calcium Supplementation on Pregnancy-Induced Hypertension and Preeclampsia: A Meta-analysis of Randomized Controlled Trials, Journal of the American Medical Association, 275:14, 1996. • Sakhaee, K., et al., Limited Risk of Kidney Stone Formation During Long-Term Calcium Citrate Supplementation in Nonstone Forming Subjects, Journal of Urology, 152:324-327, 1994.
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
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 136b1c995c24
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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