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# Multiple Violations in Lengthy Biomic Inspection
- URL: https://www.fdaweb.com/multiple-violations-in-lengthy-biomic-inspection/
- Published: 2024-05-28T12:00:00.000Z
- Updated: 2026-09-14T14:31:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157064

A 6/12-8/31/23 FDA inspection at Biomic Sciences, doing business as ION Intelligence of Nature in Charlottesville, VA, found several violations of the Federal Food, Drug, and Cosmetic Act. A just-released 5/9 Warning Letter lists violations involving adulterated human drugs, drug CGMP (current good manufacturing practice) violations, adulterated low acid canned food dietary supplements, violations of dietary supplement CGMPs, and misbranding of dietary supplement products.

The letter lists the drug CGMP violations as:

- failure to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms; and
- failure of the firm’s quality control unit to exercise its responsibility to ensure drug products manufactured comply with CGMP and meet established specifications for identity, strength, quality, and purity.

The dietary supplement CGMP violations were:

- failure to identify specifications for each component used in the manufacture of a dietary supplement;
- failure to establish product specifications for the identity, strength, and composition of the finished batch of the dietary supplement;
- failure to quarantine components before they are used in the manufacture of a dietary supplement until quality control could conduct the required review and approval of such components;
- failure of the batch product record to include all required information; and
- failure to establish and follow written procedures for calibrating instruments and controls used in manufacturing or testing a component or dietary supplement.

FDA recommends that the company engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements if ION plans to resume manufacturing drugs for the U.S. market

ION was told to respond with a list of specific steps it has taken to correct any violations and prevent their recurrence, with documentation of the steps and a schedule for completing the corrections.