483
CHEMATICS, INC.FDA 483 - CHEMATICS, INC. - March 12, 2020
Record Details
An FDA inspection of CHEMATICS, INC. in Leesburg, IN, revealed significant deficiencies in their manufacturing processes, particularly concerning the Alco-Screen 02 packaging. The firm failed to adequately validate critical process parameters, control validated process parameters, and establish proper corrective and preventive actions for product complaints, including a repeat observation. These issues indicate a lack of robust quality system controls.
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ID · ba980d35-9c38-4288-8a5d-22a216fe8ab6