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Home » FDA Warns IVD Maker PointCare For CAPA, Validation Violations
FDA Warns IVD Maker PointCare For CAPA, Validation Violations
July 7, 2011
A warning letter the FDA sent to hematology in vitro diagnostic (IVD) manufacturer PointCare Technology Inc. notes a number of cGMP violations, including that the company failed to establish and maintain design validation procedures.