Pharmaceutical industry violations in the U.S. by violation type 1991-2017

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This statistic represents the number of pharmaceutical industry violations in the U.S. from 1991 to 2017, by the type of violation. Over this time there were 12 reported violations of poor manufacturing practices in which pharmaceutical companies sold drug products that failed to meet Food and Drug Administration (FDA) standards and specifications.

Total number of pharmaceutical industry violations in the U.S. between 1991 and 2017, by type of violation

Characteristic	Number of violations
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Release date

March 2018

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Region

United States

Survey time period

1991 to 2017

Supplementary notes

* Since the publication of the 2016 report, an additional federal, non-qui-tam settlement with Syncor, in 2002 for $2.5 million ($0.5 million civil penalty; $2 million criminal penalty) for kickbacks, was found and added to the database.
** Poor manufacturing practices: selling drug products that fail to meet FDA standards or specifications (e.g., contaminated or adulterated products, or products that fail to meet size or dosage specifications).

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