Ion Labs Inc. – FDA 483, May 7, 2013

Ion Labs Inc., a dietary supplement manufacturer in Clearwater, FL, was cited for multiple significant deficiencies in its quality control and manufacturing processes during an FDA inspection. The firm failed to establish and test product specifications, confirm component identity, qualify suppliers, and properly manage reprocessed batches and unanticipated manufacturing deviations. Many of these issues were repeat observations from previous inspections, indicating a systemic lack of compliance with good manufacturing practices.