FDA 483 - Biomic Sciences, LLC dba ION Intelligence of Nature - August 13, 2021

Biomic Sciences, LLC, a dietary supplement manufacturer in Charlottesville, VA, was cited for significant deficiencies in their complaint handling and adverse event reporting procedures. The firm failed to properly review and document a product complaint involving an adverse event, and did not report a serious adverse event to the FDA via a MedWatch form, contrary to their own standard operating procedures.