What happened
Original notice title
Life Rising Corporation 5/25/17
From the archived source record
During the inspection, our investigator found a number of violations of the current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, Title 21, Code of Federal Regulations, Part 111 (21 CFR 111). These violations cause your dietary supplements 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 they have been prepared, packed, or held under insanitary conditions that do not meet cGMP regulations for dietary supplements. Based on our review, we have concluded that your products are in violation of sections 403, 505(a), and 502(f)(1) of the Act [21 U.S.C. §§ 343, 355(a), and 352(f)(1)] and regulations implementing the food labeling requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). 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). Accordingly, “ Liver Regulator-2,” “Licorice, Wheat & Date,” “Spleen Support-GPT,” “Spleen Regulator,” “Circulation Maintenance,” “Lung Support-Y,” “Liver Regulator-2,” and Lung Support” fail to bear adequate directions for their intended use and, therefore, the 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 Dietary Supplement CGMP Violations Even if the products listed above did not have disease claims which make them drugs, the dietary supplement products are adulterated. The August 30, 2016 through December 19, 2016 inspection of your facility revealed the following significant violations of the cGMP requirements for dietary supplements.
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
- 36023635aa2b
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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