FDA 483 - Solaris Pharma Corp - October 31, 2019

Sol-Gel Technologies Ltd. in Bridgewater, NJ, was inspected and cited for significant deficiencies in data integrity, deviation management, and equipment cleaning and maintenance. The firm lacked proper controls over computer systems, failed to investigate and document deviations from procedures, and did not maintain or clean laboratory equipment adequately. These issues indicate a lack of robust quality control and data integrity practices.