FDA 483 - Sun Deep Inc. - July 11, 2025

Sun Deep Inc., a finished drug manufacturer in Hayward, CA, was cited for significant deficiencies in its quality control and laboratory operations. The inspection revealed inadequate complaint investigations, a lack of complete raw data for drug product release testing, and insufficient controls over laboratory media qualification and water system testing. Several observations, including inadequate investigations and lack of TOC testing, were repeat findings from a previous FDA inspection, indicating persistent issues.