FDA 483 - YB CHEMIA LLC - October 24, 2024

YB CHEMIA LLC in Baldwin Park, CA, was inspected from October 21-24, 2024, and received two observations. The inspection revealed deficiencies in the firm's quality control unit procedures, including issues with investigating out-of-specification results and change control management. Additionally, the purified water system was found to be inadequately designed and susceptible to contamination.