FDA 483 - Sandoz Incorporated - April 16, 2019

An FDA inspection of Sandoz Incorporated in Broomfield, CO, revealed significant deficiencies in their drug manufacturing operations. The firm failed to thoroughly investigate unexplained discrepancies, including metallic particle contamination in drug products and out-of-specification water samples, without adequate health hazard assessments. Additionally, laboratory control mechanisms and system suitability failures were not properly reviewed by Quality Assurance, and packaging equipment was found to be poorly maintained, posing a risk of foreign material contamination.