美国FDA药物评价和研究中心：2024财年药品质量状况报告（英文版）（25页）.pdf

1、Center for Drug Evaluation and ResearchOffice of Pharmaceutical QualityReport on the State of Pharmaceutical QualityFY2024 ContentsIntroduction.3Manufacturing Site Demographics.4Drug Product Demographics.8Postmarket Quality Defects(PQDs).8Drug Amount Reporting.9Import Alerts,Recalls,and Warning Lett

2、ers.11Import Alerts.11Recalls.14Warning Letters.17Using Product Snapshots to Assess Quality and Illustrate Supply Chains for ADHD Drugs.19Commitment to Quality.23Sampling and Testing.23Continuing to Assure Quality.24FY2024 Report on the State of Pharmaceutical Quality|Office of Pharmaceutical Qualit

3、y 2IntroductionThe Office of Pharmaceutical Quality(OPQ)in the U.S.Food and Drug Administra-tion(FDA),Center for Drug Evaluation and Research(CDER)assures that drugs le-gally marketed in the U.S.are safe and effective,and meet quality standards.This 7th Report on the State of Pharmaceutical Quality(

4、FY20241)was produced by OPQs Office of Quality Surveillance as part of its mission to promote the availabil-ity of quality medicines for the American public.This report provides data,trends,and insights about FDA-registered drug manufacturers2 and the quality of the U.S.drug supply,including biologi

5、cal products regulated by CDER.3 Acknowledgement:The CDER Office of Compliance is acknowledged for providing data and review that supported the production of this report.1 Fiscal Year 2024(FY2024)was from October 1,2023,to September 30,2024.2 A“manufacturer”is anyone engaged in manufacturing,prepari

6、ng,propagating,compounding,processing,packaging,repackaging,or labeling of a drug.3 This report covers CDER-regulated products and excludes products regulated by FDAs Center for Biologics Evaluation and Research(CBER),e.g.,blood,vaccines,tissues,and certain other biological products.FY2024 Report on