FDA 483 - ChemWerth Pharmaceutical Technology (Shanghai) Co., LTD - April 03, 2024

During an inspection conducted from April 1-3, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 observation to ChemWorth Pharmaceutical Technology (Shanghai) Co., LTD, a contract testing laboratory. The primary observation concerned the lack of proper calibration and qualification of critical instruments used in their operations. Specifically, the FDA noted that the firm's Malvern Mastersizer 3000 instrument (equipment number Lab21102), utilized for particle size distribution (PSD) analysis, had not undergone re-qualification as recommended by the manufacturer since April 2021. This re-qualification is essential for verifying the performance of key instrument components. Furthermore, ChemWorth did not conduct a risk assessment for failing to adhere to these manufacturer recommendations. Additionally, a stand-alone sonicator (equipment number Lab16101), which is crucial for liquid sample preparations for PSD analysis, had never been qualified, despite the sonication step being identified as directly impacting PSD results. These deficiencies indicate a failure to maintain instruments in a validated and controlled state, which is critical for ensuring the accuracy and reliability of testing results in a pharmaceutical environment. ChemWorth Pharmaceutical Technology is required to respond to these observations with comprehensive corrective actions to ensure compliance with regulatory expectations.