Our new Inspections report includes tips on how to:
In 2014, the top causes for Form 483s issued to drug and device makers were:
This data is from FDA’s annual statistical report of 3,467 domestic and foreign device inspections that were scheduled from Oct. 1, 2013, through Sept. 30, 2014. During this period, the FDA issued 972 Form 483s to devicemakers, down from 1,099 in the prior fiscal year and 1,090 in 2012.
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