FDA 483 - United Laboratories Manufacturing, LLC - August 18, 2010

An FDA inspection of United 1 International Laboratories, LLC in Farmers Branch, TX, an OTC contract drug manufacturer and dietary supplement producer, revealed significant deficiencies across multiple quality systems. The firm failed to adequately validate manufacturing processes, computer systems, and equipment, and did not follow its stability testing program for OTC drugs. Additionally, issues were noted in dietary supplement manufacturing regarding identity testing, corrective action plans, complaint investigations, and contamination control, indicating a broad lack of adherence to good manufacturing practices.