US FDA ‘State Of Quality’ Report Targets Unreviewed, Uninspected Risks

16 May 2019

The poorest-quality pharmaceuticals consumed in the US are the ones FDA has never reviewed, or are from sites the agency has never inspected, regardless of country of origin; the agency’s inaugural ‘State of Quality’ report contains some surprising findings.

Dark and eerie industrial urban city street at night in Chicago - Image — Uninspected facilities making unreviewed drugs have poorest quality, FDA finds.

In its first annual report on the state of pharmaceutical quality, the US Food and Drug Administration highlighted several trouble areas – sites that make drugs the agency has not reviewed, that operate facilities it has not yet inspected, or that were involved in recalls.

The fiscal year 2018 report, issued 13 May, unexpectedly found that that on average, brand drugs drew more complaints...