Sample FDA compliant CAPA procedure wanted

P

patilrahuld

Involved In Discussions
#1
#1
Hello,

Can anyone please share their CAPA procedure with me. We are in a process of getting FDA registered and wanted to update our corrective action procedure more in line with FDA requirements.

Appreciate the help in advance.

RDP
 
GAGEpack - Gage & Calibration Management
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Y

yodon

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Super Moderator
#3
#3
I would expect that this post hasn't gotten any reaction for several reasons. For one, CAPA has been a long-standing leading cause of 483s. So maybe most folks are either worried about sharing something that might not be compliant or holding close something that has demonstrated compliance.

In your case, since you already have a CAPA procedure, why do you think yours isn't up to FDA snuff?

I presume you've read the regulation? You can find it here: http://www.ecfr.gov/cgi-bin/text-idx?SID=771895e57a8d34e12db0146c85122b79&node=sp21.8.820.j&rgn=div6

You can also get some information on what inspectors are taught to look for when reviewing your operations through the QSIT publication. Here's the link to the CAPA section: http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm170612.htm

Maybe after going through all that, you can post some specific questions. Those typically get more traction.
 
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