FDA 483 - United Laboratories Manufacturing, LLC - April 09, 2018

An FDA inspection of United I International Laboratories, LLC, an OTC drug manufacturer in Carrollton, TX, revealed multiple significant deficiencies in their quality control and record-keeping practices. Observations included failures to record and investigate deviations, use of incorrect master batch records, incomplete laboratory and in-process control results, and inadequate equipment and cleaning logs. These issues indicate a systemic lack of adherence to good manufacturing practices.