FDA 483 Warning Letter –Trend Analysis - BioClin Labs
FDA 483 Warning Letter ? Trend Analysis
Garry Wright European Laboratory Compliance Specialist RQA Regional Forum, Hodson Bay Hotel, Athlone ? Friday 13th May 2016
garry.wright@
Agenda
? FDA Warning Letter Statistics. ? Industry Offenders? ? Drug vs. Biologics Trends. ? FDA Inspectional Observational Summaries. ? Top 5 violations from 2015. ? Drug Warning Letter 2016. ? Biologics Warning letter 2016. ? Warning Letters by European Country. ? Warning Letters for Ireland. ? Change in Regulatory Focus.
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Page 2
How many Warning Letters have FDA issued in the last 10 years?
53,992 22 Warning Letters per day.....
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Page 3
Which industry is the worst offender?
FDA Warning Letter - 10 year trend
8000 7000 6000 5000 4000 3000 2000 1000
0
2006
2007
2008
2009
2010
2011
2012
2013
Food Devices Drugs Biologics Bioresearch Veterinary Others
#1 ? Food ~ 50% #2 ? Medical Devices ~ 20% #3 ? Drugs ~ 12 to 14%
#4 ? Bioresearch ~ 5 to 6% #5 ? Veterinary ~ 4 to 6% #6 ? Biologics ~ 3 to 4%
5000 ? 7000 Warning Letters issued each year.....
2014
2015
Drugs, Bioresearch and Biologics account for ~ 20% of all FDA warning letters.....
EMEAI LSAG
Page 4
FDA Warning Letters ? Drugs vs. Biologics Trend
Drug vs. Biologics - FDA Warning Letter Trend
1200
1000
275
258
237
800
299
228 195
239 600
191
146
123
400
649 572
746
758
787
690
645
678
594
498
200
0 2006
2007
2008
2009 2010 2011 2012 Drugs Biologics
2013
2014
2015
EMEAI LSAG
? Drug related warning letters represent 12 ? 14%.....
? Biologics related warning letters represent 3 ? 4%.....
? Ratio of Drug warning letters increasing to 85% (from 70%).....
? Ratio of Biologics warning letters decreasing to 15% (from 30%).....
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