FDA 483 - Ion Labs Inc. - August 02, 2012

An FDA inspection of Ion Labs Inc., a dietary supplement manufacturer in Clearwater, FL, revealed 12 significant observations, many of which were repeat violations from a previous inspection. The firm failed to establish and follow critical quality control procedures, including product and component specifications, appropriate testing, material review for non-conformances and reprocessed products, and proper handling of customer complaints. These deficiencies indicate a systemic lack of control over the manufacturing and quality assurance processes for dietary supplements.