Our new Inspections report includes tips on how to:

  • Create successful SOPs
  • Prepare for your next inspection
  • Avoid common mistakes that result in 483s

In 2014, the top causes for Form 483s issued to drug and device makers were:

  • Inadequate CAPA procedures
  • Poor SOPs
  • Lax complaint procedures

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.

To receive a FREE copy of the Inspection Insider White Paper, Drug and Device Makers Cited in 483s for CAPAs, Poor Documentation in 2014, simply provide us with the information requested below.