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Home » Aerscher Diagnostics Gets Warning for CAPA, Quality Audit Violations
Aerscher Diagnostics Gets Warning for CAPA, Quality Audit Violations
July 15, 2011
Aerscher Diagnostics, a device manufacturing firm specializing in screening tests to detect fecal or gastric occult blood, received a June 28 FDA warning letter citing numerous violations of the current good manufacturing practices (cGMP) and quality system regulation requirements, including CAPA (corrective and preventive action) violations and failure to document acceptance activities.