Review: FY 2014 Inspectional Observation Summaries

At the end of each fiscal year the US FDA posts a summary of the Inspectional Observations from Form 483. The fiscal year for the…

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Data Integrity and Form 483 or Warning Letters

Data integrity is an essential component of both clinical and nonclinical research conducted under the supervision of the Food and Drug Administration.

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FY 2013 483 Data Released; Top Ten Observations Unchanged

The US FDA released enforcement data from fiscal year 2013. The data provides the total number of Form 483 Inspectional Observations, the most common pre-enforcement…

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