Biomic Sciences, LLC dba ION Intelligence of Nature – FDA Warning Letter, Aug 31, 2023

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