Biomic Sciences, LLC dba ION Intelligence of Nature
FDA issued a warning letter to Biomic Sciences, LLC dba ION Intelligence of Nature (owner Dr. Zachary Bush) following a June–August 2023 inspection of their Charlottesville, VA facility. The agency found the ION Intelligence of Nature Sinus Support Nasal Spray to be adulterated due to gross microbial contamination (up to 1,100,000 CFU/mL), prompting a voluntary recall of all nasal spray lots. Additional violations included multiple drug CGMP failures, dietary supplement CGMP failures for Ion Gut Support, low-acid canned food registration and process-filing violations, and misbranding of dietary supplement labels. FDA warned that failure to adequately address these matters may result in seizure and injunction.
Flagged claims (1)
mineral supplement
Required actions (4)
On September 29, 2023, you voluntarily recalled all lots of ION Intelligence of Nature Sinus Support Nasal Spray, ION Sinus, and Restore Sinus Spray products to the consumer level due to microbial contamination identified as Microbacterium sp., Fictibacillus sp., Bacillus sp. (primarily B. malikii), and Paenibacillus sp.
Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market.
Please notify FDA in writing, within 15 working days of the receipt of this letter, of the specific steps you have taken to correct any violations.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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