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Product Recall procedure


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#1 Pato

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Posted 03 April 2018 - 08:55 PM

Hi all,

 

Could anyone share a Recall/withdrawal procedure under EC regulations? I have so many things to do (with actual 0 experience in QA) that my brain stopped working I'm stuck!!! :crybaby:

 

Thanks in advance.

 

Cheers

 

Pato



#2 Ansh3

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Posted 04 April 2018 - 05:21 AM

Dear Pato,

 

You can go to this link for guidance 

 

http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm

 

I modeled most my recall based on the attached document. It's pretty comprehensive, and it takes care of EU requirements too. Hope it helps.

 

On another note, I completely agree that setting up QA becomes overwhelming , but keep in mind that there are others who are more qualified but still unemployed. Make use of the experience you are getting despite having no experience in it. 

 

 

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#3 Pato

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Posted 04 April 2018 - 07:28 PM

Hi PTGC,

 

Thank you very much my friend! I'm the factory manager in a small fish factory and QA is one of my duties, it is incredible how busy this place can get.

 

Your help is much appreciated.

 

Cheers

 

Pato






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