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Allergen and sanitation in USDA room under FSIS inspection and FDA room

FDA ROOM

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#1 rgiuliano137

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Posted 29 September 2020 - 03:06 PM

Ok we have a facility with 2 rooms, one is a USDA room under fsis inspection, the other room is an FDA room packing seafood, however the owner of the facility wants to run frozen IQF chicken and catfish and swai in the FDA room, obviously my concern is allergens plus sanitation, i really do not think that the USDA inspector onsite will go for this, what would anyone do in this scenario?

 



#2 rgiuliano137

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Posted 29 September 2020 - 03:10 PM

oh forgot to mention, USDA room is an rte room packing a cheese and meat item and the chicken and catfish are raw which is why i will not use USDA room



#3 TimG

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Posted 29 September 2020 - 03:19 PM

USDA can maintain inspection on facilities (or rooms in this case) that also handle FDA. Your concern is valid, and you would have to perform a thorough risk assessment prior to running the new product.

If you do perform the assessment and it passes I don't see how the USDA person can not go for it. I've worked in facilities with rooms that were under regs for both USDA and FDA.

You would no longer have a USDA and an FDA room, it would be an RTE and a raw's room. Also, with FSIS understand and expect that they will nail you for non-conformities even when running your FDA governed product, if they are there and they observe them.


Edited by TimG, 29 September 2020 - 03:20 PM.


#4 rgiuliano137

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Posted 29 September 2020 - 03:53 PM

Thank you Tim G, My boss wasnt having any of this until i copied your response, i told him in an earlier meeting everything you mentioned in your response, glad we are on the same page.

 

regards

 

Roberto Giuliano in Illinois



#5 rgiuliano137

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Posted 01 October 2020 - 01:53 PM

Tim

 

i was wondering if you could share a copy of your risk assessment.

 

thank you



#6 TimG

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Posted 01 October 2020 - 03:53 PM

Hey RG, that RA was in a previous place of employment and I no longer have access. I recall it was fairly involved. The allergen and sanitation programs had to be amended as a result, not to mention the new product food safety plan/HACCP-PC that had to be created for the FDA product introduced into the USDA facility.






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