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Are food/dietary supplement warehouses required to have a food safety plan?


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#1 jbell4711

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Posted 31 July 2020 - 12:42 AM

Do warehouses need to have a food safety plan? We will be storing our dietary supplements in a warehouse that stores alcohol and food. Is this a FSMA requirement?



#2 Slab

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Posted 31 July 2020 - 05:17 AM

In short, yes. The FDA considers the holding or storing of commodities as "processing" and you need to be compliant at a minimum to 21 CFR part 117.

 

There are some exemptions (seafood, dairy, juice, and some farm activities) to most parts of 117. To what extent your development of a food safety plan depends on risk assessment and hazard analysis to parts 117 and 121. Also, there are small entity exemptions under DSHEA you may want to look into.


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#3 SQFconsultant

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Posted 31 July 2020 - 12:08 PM

Agreeing with what Slab said and adding that a client doing the same as your facility has a full food safety/haccp plan in place. They also are SQF certified but even if not would still need to have this.


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#4 jbell4711

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Posted 31 July 2020 - 05:08 PM

Hi Glenn,

 

According to our consultant, she said to reference 21CFR117.7, which says that we should be exempt. Any thoughts on that?



#5 Slab

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Posted 31 July 2020 - 05:47 PM

Hi Glenn,

 

According to our consultant, she said to reference 21CFR117.7, which says that we should be exempt. Any thoughts on that?

If the commodity meets the exemptions outlined in 117.7 then it would be exempt to subparts C, D, and G as long as modified requirements are met under 117.206.

 

I suppose this is in the fog of FDA verbiage a prerequisite program... or under a HACCP system a CCP. I'm sure there is method to the madness, but damned If I know.


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