Preparing a Site for FDA Audits-09012009.ppt

2 Who Gets Audited? Everyone Randomly www.amarexcro.com ©Amarex, LLC 7 Selected Few: high priority targets When there is an accident Who Gets Audited by FDA? File for an approval application NDA/PMA High Risk Product zUsed in vulnerable population zUsed in large populations www.amarexcro.com ©Amarex, LLC 8 Used in …