L
Hi All,
I heard fairly recently that the FDA had put out a new requirement that all Contract Medical Device manufacturers as well as all Contract Sterilizers, must have some form of CAPA system in place. Can anyone shed some light on this subject? Is there a new regulation laid out in the CFR or any other place that someone could point me to?
Thank you in advance for your help,
Larry
I heard fairly recently that the FDA had put out a new requirement that all Contract Medical Device manufacturers as well as all Contract Sterilizers, must have some form of CAPA system in place. Can anyone shed some light on this subject? Is there a new regulation laid out in the CFR or any other place that someone could point me to?
Thank you in advance for your help,
Larry