Distribution Center has shipped Sterile Medical Device products that have Expired

M

MonkeyMayhem

#1
Hi
Just found out that our third party distribution centre have shipped sterile medical device products that have expired to a customer/s. The sterility certificates have expired. What do I do? What are my options?
I have put a block on the rest of the batch. Is this a FSCA (Field Safety Corrective Action)?
Thanks
 
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W

William_55401

#2
Hi. I agree with your action to contain the product. When you say sterility certificates have expiried, I am assuming this means product was shipped after the expiry date on the packaging / labeling. If this is the case, it sounds like there is a hazard and CFR 806 (Corrections and Removals) is in play and a correction / removal is required. What does your QS tell you to do? Does your CAPA procedure have a risk / hazards analysis tool that drives you to a correcions / removal decision? When looking at product performance issues, the analysis and decision making is grey. When looking at sterility, it is a much easier / simpler decision. 820 also requires you to ensure that devices that can deteriorate are not distributed. I think you are headed towards a correction. I encourage you to look at your distribution controls to see how short dated product (product with say 6 months or less shelf life) is handled. Hope this helps.
 
A

Alexisss

#3
In which country/geographic area of the planet is the distribution center, and which area did they ship to ?
 
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