2 replies to this topic

[Pato]

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!!!

 

Thanks in advance.

 

Cheers

 

Pato

[Ansh3]

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. 

 

 

Attached Files

•  fs10800- Mock recall.pdf   998.66KB   358 downloads

[Pato]

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