USA – FDA’s drug quality report card details enforcement trends, increased inspections in 2022

In its latest State of Pharmaceutical Quality report, the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) cited an increase in the number of non-compliant drug samples tested in FY 2022 compared with recent years and noted a growing number of recalls. It also found that the number of surveillance inspections “nearly tripled” in 2022 in a shift toward pre-COVID-19 levels.

The report is the fifth annual State of Pharmaceutical Quality report from OPQ, and it presents key data that characterize drug and manufacturing site quality. This includes data from inspections, product quality defects, import alerts and recalls…