483
Cirtec MedicalCirtec Medical – FDA 483, Mar 8, 2023
Record Details
Cirtec Medical in Los Gatos, CA, a contract manufacturer, was cited for inadequate corrective and preventive action procedures. The inspection revealed that the firm failed to open a CAPA to investigate and correct discrepancies in heat sealer calibration parameters. This lapse affected multiple lots of product manufactured prior to the correction, indicating a significant control deficiency.
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ID · 7936291d-e3d9-44f2-83a4-1f67e362ceae
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