# FDA WARNING_LETTER - Biomic Sciences, LLC dba ION Intelligence of Nature - August 31, 2023

Source: https://www.keypedia.com/records/warning_letter/biomic-sciences-llc-dba-ion-intelligence-of-nature/9b07b7f3-7791-4e6c-8269-37fc813e34e6

> FDA WARNING_LETTER for Biomic Sciences, LLC dba ION Intelligence of Nature on August 31, 2023. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Biomic Sciences, LLC dba ION Intelligence of Nature
- Inspection Date: 2023-08-31
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: The FDA issued a Warning Letter to Dr. Bush following an inspection of the facility at 4351 Seminole Trail, Charlottesville, VA, from June 12 to August 31, 2023. The inspection and subsequent product label/website review revealed significant violations of the Federal Food, Drug, and Cosmetic Act.

Key violations include:

**Adulterated Human Drugs:**
*   **ION Intelligence of Nature Sinus Support Nasal Spray:** FDA testing found gross microbial contamination (510,000-1,100,000 CFU/mL total aerobic microbial count; 290-1,100 CFU/mL total yeast and mold counts), including *Microbacterium sp.*, *Fictibacillus sp.*, *Bacillus sp.*, and *Paenibacillus sp.* This product was deemed adulterated under 21 U.S.C. 351(a)(1). The firm voluntarily recalled all lots of this product on September 29, 2023.

**Drug CGMP Violations (21 CFR Parts 210 and 211):**
*   **Failure to Conduct Appropriate Laboratory Testing (21 CFR 211.165(b)):** Finished drug products were released without adequate microbial testing, particularly for objectionable microorganisms in a nasal spray. Preservatives were used

## Related Documents

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## Related Officers

- [Director of Compliance Branch](https://www.keypedia.com/people/robin-m-rivers/eaef5b9e-6d67-4968-b1d6-7e9091f837fa)

Company: https://www.keypedia.com/companies/biomic-sciences-llc-dba-ion-intelligence-of-nature/63ae5f3c-ccc9-4a35-a421-11de28797355

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e