What happened
Original notice title
GnuPharma Corp. 12/13/17
From the archived source record
During the inspection, our investigators found 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 Part 111). These violations cause your GnuPharma products 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 found under 21 CFR Part 111. We have also reviewed your GnuPharma Corporation websites, www.gnupharma.com and www.gnuwellness.com in June 2017 and again in November 2017, and the product labels for the products you manufacture and distribute. Based on our review, we have concluded that your Relief capsules, Foundation capsules, Aller-geez capsules, Fit capsules, Aller-Geez Tea, Foundation herbal tea, Relief Tea, Relief Herbal Aromatherapy, and your HNR (all flavors) Herbal Aromatherapy are in violation of section 505(a) of the Act [21 U.S.C. §§ 355(a)]. We have also reviewed the product labels for your Relief, Foundation, Fit, and Sleep capsules, and based on our review, we have concluded that these products are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. Unapproved New Drugs The Food and Drug Administration (FDA) reviewed your product labels and your website at the internet addresses www.gnuwellness.com and www.gnupharma.com in June 2017 and again in November 2017, and determined that you take orders there for your products Relief capsules, Foundation capsules, Aller-geez capsules, Fit capsules, Aller-Geez Tea, Foundation herbal tea, Relief Tea, Relief Herbal Aromatherapy, and HNR (all flavors) Herbal Aromatherapy.
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
- 80c6359a0d5f
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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