Good morning everyone. Does anyone out there have a simple CAR that can be used for replies to a FDA audit, thanks.
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jalex194021
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Posted 07 August 2018 - 12:36 PM
#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/
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