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Simple Corrective Action Form for replying to an FDA audit?


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#1 jalex194021

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Posted 07 August 2018 - 12:36 PM

Good morning everyone. Does anyone out there have a simple CAR that can be used for replies to a FDA audit, thanks.



#2 FSQA

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Posted 07 August 2018 - 03:41 PM

Good morning everyone. Does anyone out there have a simple CAR that can be used for replies to a FDA audit, thanks.

CAR should include Company name and info, Observation/Findings quoted by the auditor, Corrective action, preventive action and a date of implementation. Supporting documents/pictures of the correction can also be helpful.

 

Please see following for some examples of templates shared by our fellow IFSQN users in the past:

 

http://www.ifsqn.com...-ncrs-and-cars/



#3 Brissy

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Posted 15 January 2020 - 01:41 AM

CAR should include Company name and info, Observation/Findings quoted by the auditor, Corrective action, preventive action and a date of implementation. Supporting documents/pictures of the correction can also be helpful.

Please see following for some examples of templates shared by our fellow IFSQN users in the past:

http://www.ifsqn.com...-ncrs-and-cars/






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