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Preventive Controls for the biological hazards in raw cherries


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#1 jalex194021

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Posted 27 November 2018 - 09:11 PM

We had a FDA inspection this summer, and we were told that we have no preventive control for the biological hazards associated with raw cherries. And, if the control is applied at another manufacturer we must get a letter stating that, 117.136(a)(2)(i).......we chlorinate our water, so what other control would we be looking for????????????


Edited by jalex194021, 27 November 2018 - 09:22 PM.


#2 LisaZ

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Posted 27 November 2018 - 10:28 PM

Maybe storage temperatures?



#3 vuthingocdao

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Posted 28 November 2018 - 08:53 AM

Maybe this example be useful for you.

Attached Files



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#4 jalex194021

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Posted 28 November 2018 - 12:45 PM

Maybe storage temperatures?

The finished product is shipped directly into a freezer at a temperature of -15 degrees.



#5 jalex194021

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Posted 28 November 2018 - 12:47 PM

Maybe this example be useful for you.

 

This is basically what we do, that is why we are a little confused on this.



#6 PieGuy191

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Posted 28 November 2018 - 07:40 PM

Here is what we have for a Hazard Analysis and Supply Chain Controls for Frozen Pitted Cherries.  Maybe this will help.  We had our FDA Preventive Controls audit in February and they were okay with this then.

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#7 kfromNE

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Posted 28 November 2018 - 08:11 PM

These might be of help.

 

https://www.ncrfsma....esources-topic 

 

https://www.ncrfsma....y-organizations



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#8 CMHeywood

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Posted 28 November 2018 - 08:31 PM

What are the other potential sources of biological contamination?

 

Unwashed hands.

Dirty equipment.

Contaminated storage areas.

Pests carrying bacteria.

Unclean shoes or clothing.

Etc.

 

Do you have prerequisitie programs to cover these?



#9 jalex194021

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Posted 28 November 2018 - 08:35 PM

Here is what we have for a Hazard Analysis and Supply Chain Controls for Frozen Pitted Cherries.  Maybe this will help.  We had our FDA Preventive Controls audit in February and they were okay with this then.

Are you receiving the cherries already IQF?



#10 jalex194021

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Posted 28 November 2018 - 08:36 PM

What are the other potential sources of biological contamination?

 

Unwashed hands.

Dirty equipment.

Contaminated storage areas.

Pests carrying bacteria.

Unclean shoes or clothing.

Etc.

 

Do you have prerequisitie programs to cover these?

 

Yes we do, this is where the confusion is coming from



#11 PieGuy191

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Posted 28 November 2018 - 08:46 PM

Are you receiving the cherries already IQF?

Yes we are.



#12 Charles.C

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Posted 29 November 2018 - 01:16 AM

We had a FDA inspection this summer, and we were told that we have no preventive control for the biological hazards associated with raw cherries. And, if the control is applied at another manufacturer we must get a letter stating that, 117.136(a)(2)(i).......we chlorinate our water, so what other control would we be looking for????????????

 

Hi jalex,

 

So what were the specific biological hazards in yr harpc plan which FDA apparently did require to be prevented ?

(might be convenient to post yr harpc plan)

 

@ Pie Guy - Thks yr input. Nice layout although I have a few reservations about content, eg -

In view of FDA's published views on foreign material hazards, IMO the cherry pits in yr plan should not require a PC.

The justifications given for no required PCs for biological/pesticide hazards seem like  fudges to me unless some futher  corroborative data was specifically/additionally provided, eg official micro. appraisals of the raw cherry supply industry and/or local testing of incoming material lots.

 

Nonetheless, I am not in USA so perhaps these are implicitly/officially approved fudges


Kind Regards,

 

Charles.C


#13 sqflady

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Posted 29 November 2018 - 01:46 PM

The storage temperature is also a process control.



#14 jalex194021

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Posted 29 November 2018 - 06:26 PM

Here is what we have for a Hazard Analysis and Supply Chain Controls for Frozen Pitted Cherries.  Maybe this will help.  We had our FDA Preventive Controls audit in February and they were okay with this then.

Question, on your HA, how do you know what is appropriate for your suppliers preventive control? And what is your PC if you don't mind me asking?






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