FDA Permits Company to Continue Issuing Key U.S. Drug Ingredients despite Quality Concerns

August 5, 2016 | Strategic Insights for Ambulatory Care


​To combat shortages of critical prescription drugs in the United States, the U.S. Food and Drug Administration (FDA) is allowing a Chinese manufacturing plant that it previously banned indefinitely from exporting to the United States to continue to export 15 ingredients for use in finished drugs in the United States, states a July 22, 2016 article in Bloomberg. In March 2015, an FDA inspection led to the ban of 15 products produced by the company because of significant quality concerns, including missing audits, modified test records, and in one case, an employee who fled with what appeared to be a thumb drive.

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