Read the full article: An Alternative to GMP Quality System Auditing in the Pharma Industry | FDAZILLA BLOG:
"Over the past four FDA fiscal years, the percent of warning letters that cite data integrity deficiencies has continued to increase"
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Showing posts with label deficiencies. Show all posts
Showing posts with label deficiencies. Show all posts
Wednesday, January 18, 2017
Tuesday, December 9, 2014
The Top 15 Medical Device Deficiencies Cited by FDA in 2014 | RAPS
"The US Food and Drug Administration (FDA) has released data on the observations it makes during inspections of medical device facilities, indicating the most common issues faced by medical device companies.
Total 483s Issued Declines for First Time in Six Years"
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View FDA Inspection Data:
FY 2014 Inspectional Observation Summaries - Number of 483s Issued from the System (Inspections ending between 10/1/2013 12:00:00 AM and 9/30/2014 12:00:00 AM)
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