483
DB Diagnostic Systems Inc.FDA 483 - DB Diagnostic Systems Inc. - July 16, 2019
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An FDA inspection of BB Diagnostic Systems Inc., a medical device establishment in Juno Beach, FL, revealed significant deficiencies in their quality system. The firm's procedures for supplier qualification, software validation, and finished device acceptance were found to be inadequate. These issues indicate a lack of robust controls over critical operations and product quality.
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ID · 4a14e2bf-2859-4c02-9ea2-16e10fa81ba4