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Report on the State of Pharmaceutical Quality

Fiscal Year 2023 Report on the State of Pharmaceutical Quality Cover Image

FY 2023 Report on the State of Pharmaceutical Quality (PDF - 8 MB)

Everyone deserves confidence in their next dose of medicine. A quality medicine is safe, effective, and available for the people who need it. The Office of Pharmaceutical Quality’s mission is to assure that quality medicines are available to the American public. Drug manufacturers are responsible for complying with regulations and ensuring their products meet quality standards. Quality is complex, involving the product, process, facility, and supply chain. There is no single tool that can assure quality, but a combination of complementary tools can make it feasible to surveil the U.S. pharmaceutical market. The Report on the State of Pharmaceutical Quality is published annually to share key quality data, assessment of trends, and insights about quality surveillance programs with the public. 

The annual Report on the State of Pharmaceutical Quality is intended to help characterize the quality of the U.S. drug supply chain. It is updated each year to provide current and cumulative data about pharmaceutical manufacturers, their products, and postmarket quality defects. In addition, this report provides insights about import alert additions, recalls, and warning letters.  The report also highlights emerging approaches to surveil, characterize, and advance pharmaceutical quality. FDA uses the Report on the State of Pharmaceutical Quality, in part, to inform regulatory decision making and quality surveillance activities.

The Report on the State of Pharmaceutical Quality from Previous Years

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