CAPA Problems - Most often cited 483 deficiency

You'll do well by reading this well-written article by Barbara Immel, "Converting CAPA to an Advantage - CAPA violations still generate a substantial number of warning letters. These tips can help make CAPA systems a benefit instead of a liability." Her writings are packed full of great content. Don't miss out on these pearls of wisdom and well referenced article.

In concluding, she writes, "CAPA deficiencies are one of the most common items cited in warning letters to medical device manufacturers. Therefore, it is critical for manufacturers to understand how to develop a CAPA system and how best to use it. . . ."

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FDA 483 Inspectional Observations - learn from these examples

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