FDA Produces List of Common Deviations Found During Lab Inspections

Did You Know?

During 2010, the FDA performed a large number of regulatory inspections and has compiled a list of the most common deviations found. According to www.labcompliance.com, 19 percent of the devations found on the list were "related to unvalidated lab test methods," and that "laboratory controls [issues] ranked as number 1." Additional data points of interest also include quality system and production process control systems which rank at 9 percent and 6 percent respectively. Also according to labcompliance, it was found that lab control deviations were found to be highest in China (at 28 percent).

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