FDAnews
www.fdanews.com/articles/138342-fda-warns-ivd-maker-pointcare-for-capa-validation-violations

FDA Warns IVD Maker PointCare for CAPA, Validation Violations

July 13, 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.
The GMP Letter