FDA 483 - Strides Pharma, Inc. - February 20, 2022

An FDA inspection of Strides Pharma, Inc. in Chestnut Ridge, NY, a drug manufacturer, revealed significant deficiencies in both laboratory control mechanisms and packaging/labeling operations. The firm failed to properly document laboratory analyses, ensure QC review, and maintain appropriate sample storage. Additionally, inadequate cleaning procedures led to residual labeled materials on packaging lines after batch runs.