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Can you Rework a Recall?


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#1 jfox1

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Posted 04 March 2019 - 07:41 PM

My company processes grain and makes Animal Feed. If we were to have to have a recall due to something like FM but we knew it happened after our screening/sorting process, could we receive the product back and rework it through our system to remove the FM? 

 

Is there any regulation that would prevent us from doing this? 

 

Thanks in advance! 



#2 FSQA

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Posted 04 March 2019 - 08:34 PM

My company processes grain and makes Animal Feed. If we were to have to have a recall due to something like FM but we knew it happened after our screening/sorting process, could we receive the product back and rework it through our system to remove the FM? 

 

Is there any regulation that would prevent us from doing this? 

 

Thanks in advance! 

jfox1,

 

Recalled product can be reworked, and hazard that was determined for the basis of the recall can be removed (FM) or corrected ( as in case of an allergen labeling-if possible). 

However, IMO: i would recommend contacting the regulatory body (FDA/USDA/Other) to confirm the introduction of the recalled/reworked product back into commerce.

 

Though, I am not aware of any such regulation.



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#3 SQFconsultant

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Posted 04 March 2019 - 09:10 PM

I am not aware of any regulation on it. 

 

However, the thought of this makes me cringe.

 

My question is - what would you procedure be for reworking it?


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#4 Charles.C

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Posted 05 March 2019 - 06:39 AM

My company processes grain and makes Animal Feed. If we were to have to have a recall due to something like FM but we knew it happened after our screening/sorting process, could we receive the product back and rework it through our system to remove the FM? 

 

Is there any regulation that would prevent us from doing this? 

 

Thanks in advance! 

 

Why do you want to rework ?

 

eg what is nature / level of believed FM contamination ?

 

Regulations (if any) tend to be "specific".


Kind Regards,

 

Charles.C


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#5 jfox1

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Posted 05 March 2019 - 01:35 PM

Well the obvious answer is to recover money. I personally would not want to rework but if our screening, cleaning, and or magnets could produce a quality product again and the hazard would be removed I could see the push back from the company to recover losses if possible. Again I was just wondering if there were any regulations on that. Thanks for all your help. 



#6 Setanta

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Posted 05 March 2019 - 02:01 PM

With all of that work, time, overhead, energy, etc. are you really recouping anything?


-Setanta         

 

 

 


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#7 Scampi

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Posted 05 March 2019 - 05:41 PM

I agree with Sentanta, you're going to be further in the hole, unless of course your FM is gold flakes!!

 

 

Rework is incredible expensive AND the FDA may end up saying to bad so sad

 

Never mine it just isn't right, and if customers ever caught wind...........well you know


Because we always have is never an appropriate response!


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#8 redfox

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Posted 07 March 2019 - 07:21 AM

Hello,

 

You can do re-working as long as long as you can eliminate or be sure that the reworked product could not affect or would not introduced hazard to the new product. First you have the re-working procedure. How many percent of reworked product would be added to the "virgin" material to create new product.

 

Reworking is costly, but it could really hurt the business if you throw away the recoverable material. If possible, do the things that could avoid reworking.

 

regards,

redfox



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#9 jfox1

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Posted 07 March 2019 - 01:13 PM

@Setana and Scampi - There is a very specific time when I would ever consider this. Basically we manufacture animal feed and I was thinking about if there was an instance where we had to recall due to possible FM contamination after our processes and we were confident that our process steps (screeners/cleaners etc...) would remove all of the FM. While I agree that it would probably not be worth the risk our powers that be may not agree with that. So I was specifically asking about regulations prohibiting that.

 

@redfox - Thank you for your comment. I agree that we would need to add it to our recall/rework procedure. For us reworking in the scenario I am proposing may not be any more costly then our regular procedures. I agree though we should do as much on the front end to avoid this scenario. 



#10 Scampi

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Posted 07 March 2019 - 02:17 PM

AFAIK there are not any existing regualtions that would prevent you from re-working said material UNLESS the powers that be get involved and specifically state that it must be disposed

 

In Canada in poultry if there is an issue and product is being disposed, it has to be denatured to prevent it from appearing as food fit for consumption

 

Found some actual FDA information

  • Determine and provide your course of action for out-of-business distributors.
  • Provide a proposed method of destruction, if applicable.
  • If the product is to be "reconditioned", explain how and where the reconditioning will take place. Please provide details of the reconditioning plan to your local FDA District Recall Coordinator before implementation. All reconditioning must be conducted under any applicable CGMPs.
  • Describe how reconditioned product will be identified so it is not confused with recalled (pre-reconditioned) product.

In addition, we recommend that:

  • You contact your local FDA District Recall Coordinator prior to product destruction. FDA will review your proposed method of destruction and may choose to witness the destruction.
  • The recalling firm and customers keep adequate documentation of product destruction (and whether or not destruction was witnessed by an FDA investigator).
  • Field corrections, (i.e. product relabeling), be performed by recalling firm representatives, or under their supervision and control. It is not recommended that a disinterested party such as a wholesaler or retailer be responsible for field corrections. For Drug Recalls: Misbranded drugs for re-labeling should be returned to the recalling firm.
  • You contact your local District Recall Coordinator prior to release of reconditioned goods.

 

https://www.fda.gov/...e/ucm129259.htm


Because we always have is never an appropriate response!


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#11 FSQA

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Posted 07 March 2019 - 02:33 PM

 

 

Found some actual FDA information

  • If the product is to be "reconditioned", explain how and where the reconditioning will take place. Please provide details of the reconditioning plan to your local FDA District Recall Coordinator before implementation. All reconditioning must be conducted under any applicable CGMPs.
  • Describe how reconditioned product will be identified so it is not confused with recalled (pre-reconditioned) product.

In addition, we recommend that:

  • You contact your local District Recall Coordinator prior to release of reconditioned goods.

 

https://www.fda.gov/...e/ucm129259.htm

Thanks Scampi,

 

This is what i was referring to in my post above (post # 2).



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