Home » FDA Warns IVD Maker PointCare for CAPA, Validation Violations
FDA Warns IVD Maker PointCare for CAPA, Validation Violations
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.
The GMP Letter
The GMP Letter
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