FDA 483 - K.C. Pharmaceuticals, Inc - January 30, 2020

K.C. Pharmaceuticals, Inc. in Pomona, CA, a sterile OTC eye drop manufacturer, was cited for multiple deficiencies during an FDA inspection from January 22-30, 2020. The observations primarily concern inadequate investigations into discrepancies, insufficient microbial control, and a lack of established procedures for preventing contamination and validating manufacturing processes. These issues indicate significant concerns regarding the firm's aseptic processing and quality control systems.