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CAPA system

CAPA:  A Review of 21 C.F.R. §820.100 and FDA Warning Letter Trends

CAPA: A Review of 21 C.F.R. §820.100 and FDA Warning Letter Trends

SPK and Associates routinely review warning letters to help our clients stay in step with FDA trends.   One of the problem areas most often cited in company audits continue to be the CAPA system/program.   This month we will take a look at some of the latest FDA...