FDA 483 - ChemWerth Pharmaceutical Technology (Shanghai) Co., LTD - April 01, 2024
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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.
- Inspection Date
- April 1, 2024
- Product Type
- Drugs
ID · a3be8755-61cd-4c79-9a64-45adc3798a85