FDA 483 - ChemWerth Pharmaceutical Technology (Shanghai) Co., LTD - April 01, 2024

ChemWerth Pharmaceutical Technology (Shanghai) Co., LTD, a contract testing laboratory, was inspected by the FDA from April 1-3, 2024. The inspection revealed a significant issue regarding the calibration and qualification of instruments used for particle size distribution analysis. Specifically, the firm failed to re-qualify a Malvern Mastersizer 3000 and did not qualify a stand-alone sonicator, indicating a lack of adherence to established programs for instrument control.