FDA 483 - K.C. Pharmaceuticals, Inc - December 30, 2009

An FDA inspection of B & C Pharmaceuticals Inc in Pomona, CA, a sterile ophthalmic drug and device manufacturer, revealed significant deficiencies in their quality system. Observations included inadequate validation of aseptic filling processes with multiple failed media fills, insufficient investigations into discrepancies, and a deficient environmental monitoring program. The firm also had issues with equipment design, calibration procedures, and record-keeping for critical manufacturing and laboratory instruments.