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【Full text translation】 FDA's fiscal 2021 drug quality status report

 Last Update: 2022-09-08
 Source: Internet
 Author: User

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The U.

Highlights of the report are summarized below:

Production Site Statistics: Over the past three years, the top five countries on the list (USA, India, China, Germany and Canada) saw net growth

Drug Statistics: In FY2021, the catalog contained 12,428 ANDAs, 3,537 NDA and 315 BAS

Quality Condition Study: OPQ's analysis reveals the relationship between on-site inspections and recalls

In FY21, the percentage of non-compliant samples was 35%, 16% higher than in FY2020 due to: nitrosamine-contaminated products, high non-compliance rates for hand sanitizers, and more

The FDA has made progress in two initiatives (NIPP and QMM) that are building better tools to characterize the quality of drug manufacturing sites

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