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Expect More CAPA- and QSIT-Driven Inspections
May 6, 2010
Pharmaceutical companies can learn much from analyzing medical device warning letters as well. Warning letters for medical device companies in 2008 and
2009 were focused on a subset of the FDA’s quality systems inspection technique (QSIT) methodology, known informally as CAPA+one. Five of the most frequently cited violations, in order of frequency, were ...