FDA EIR - Wasatch Product Development, LLC - March 11, 2011

An FDA routine surveillance inspection of Wasatch Product Development, LLC, a contract manufacturer of OTC drug products, cosmetics, and dietary supplements, was conducted from March 7-11, 2011. The inspection focused on OTC drug manufacturing processes, operating under Compliance Program 7356.002 and identifying significant deviations from Current Good Manufacturing Practices (cGMP) outlined in 21 CFR. The agency issued a 10-item Form FDA 483, highlighting critical issues. Main violations included unvalidated manufacturing processes and equipment, incomplete batch production and control records, and a failure to thoroughly investigate unexplained discrepancies and out-of-specification results for water purity and product viscosity. The firm's purified water system lacked validation and proper testing for total organic carbon and conductivity. Furthermore, procedures for identifying and storing components were not consistently followed, with inventory discrepancies and illegible material status labels noted. Other observations covered unvalidated cleaning, uncalibrated equipment, inadequate laboratory sampling plans, non-adherence to production procedures, and insufficient labeling controls. Company management acknowledged the observations and committed to implementing necessary corrective actions, including validating processes and equipment, improving record-keeping, enhancing investigation protocols, and validating the water system. A written response detailing these actions was required within 15 days.