What happened
Original notice title
Reishi D. International, Inc. MARCS-CMS 537352, February 06, 2018
From the archived source record
The inspection revealed serious violations of the Current Good Manufacturing Practice (cGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements Regulation Title 21 Code of Federal Regulations (CFR), Part 111, (21 CFR 111). These violations cause your Reishi D. dietary supplement product 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 product has been prepared, packed, or held under conditions that do not meet cGMP requirements for dietary supplements. Additionally, during the inspection of your facility, our investigator collected labels and brochures for your Reishi D. dietary supplement which contain violations of the Act and applicable regulations. Unapproved New Drugs We have determined that the claims on your product brochures that are distributed with your Reishi D. product establish that your Reishi D. dietary supplement product is a drug within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because it is intended for use in the cure, mitigation, treatment, or prevention of disease. Adulterated Dietary Supplements Even if your product labeling did not have therapeutic claims which make your Reishi D. product an unapproved new drug, it would still be an adulterated dietary supplement within the meaning of section 402(g)(1) of the Act [21 U.S.C. §342(g)(1)] because the product has been held under conditions that do not meet the Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (CGMP) regulations, Title 21, Code of Federal Regulations , Part 111 (21 CFR Part 111). As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of that product are in compliance with dietary supplement CGMP requirements.
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
- 495dc8d21130
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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