What happened
Original notice title
Healthtex Distributors, Inc. MARCS-CMS 654453, June 15, 2023
From the archived source record
The inspection revealed serious violations of FDA’s regulation 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 Part 111). These violations cause your dietary supplement 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 conditions that do not meet CGMP requirements for dietary supplements. We also reviewed your product labeling we collected during the inspection, and found serious violations under Title 21, CFR Part 101, which render your Dr. Sana Orange Blossom Flower Water dietary supplement products misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. We received your correspondence sent electronically on February 22, 2023 concerning our inspectional observations listed on the FDA-483, Inspectional Observations, issued to you at the close of the inspection. Adulterated Dietary Supplements Your dietary supplement products are adulterated dietary supplements under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements. During the inspection, FDA investigators observed the following significant violations of CGMP regulations for dietary supplements: 1. Misbranded Dietary Supplements In addition, your Dr. Sana Orange Blossom Flower Water products are misbranded dietary supplements under Section 403 of the Act [21 U.S.C. § 343] because they do not comply with the labeling requirements for dietary supplements as required by 21 CFR 101 as follows: 1.
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
- FDA closeout listed
- Source checked
- Jul 16, 2026
- Record revision
- e95d2a1b8688
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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