FDA 483 - Ion Labs Inc. - June 03, 2011

Ion Labs Inc. in Clearwater, FL, a dietary supplement manufacturer, was cited for significant quality control and documentation deficiencies. The firm failed to establish product and component specifications, lacked data to support label claims and expiration dates, and distributed reprocessed and out-of-specification products without proper approval or rejection. Additionally, batch production records were incomplete, missing critical manufacturing details and personnel initials.