What happened
Original notice title
Biomic Sciences, LLC dba ION Intelligence of Nature MARCS-CMS 667601, May 09, 2024
From the archived source record
Based on inspectional findings and review of the product labels collected during the inspection, as well as review of your website at www.Intelligenceofnature.com, we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Adulterated Human Drugs FDA Tested Samples FDA conducted laboratory testing of a lot of ION Intelligence of Nature Sinus Support Nasal Spray drug product and results demonstrate that this drug product is adulterated within the meaning of section 501(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 351(a)(1), in that it consists in whole or in part of any filthy, putrid, or decomposed substance. FDA laboratory analysis determined that a sample of your ION Intelligence of Nature Sinus Support Nasal Spray drug product was grossly contaminated with microorganisms. This gross contamination is particularly concerning because your drug product is a nasal spray. FDA laboratory testing of ION Intelligence of Nature Sinus Support Nasal Spray drug product lot 2302081HGA found gross microbial contamination. Therefore, this drug product is adulterated under section 501(a)(1) of the Act. The high bioburden in conjunction with the route of administration with this drug product poses a high risk of harm to vulnerable patients. During the teleconference, you agreed to conduct a voluntary recall of all lots of ION Intelligence of Nature Sinus Support Nasal Spray. Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Act, 21 U.S.C. 351(a)(2)(B). During our inspection, our investigators observed specific violations including, but not limited to, the following. 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
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- f45e6609f741
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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