FDA 483 - HLSCIENCE CO.,LTD - November 15, 2024

HLSCIENCE CO., LTD, a manufacturer in Chungju, Korea, was cited with nine observations during an FDA inspection. The firm demonstrated significant deficiencies across its quality system, including a lack of validated test methods, inadequate stability data, incomplete product release testing, and insufficient process and cleaning validations. Furthermore, critical quality control procedures, data integrity measures, and employee GMP training were found to be absent or deficient.