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FSMA - Domestic Supplier Approval


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nevin2756

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Posted 08 August 2022 - 08:50 PM

Hello,
I work in food distribution center that basically sell all different types of grocery food product except live seafood product. 
 
FSMA Final Rule for Preventive Controls for Human Food | FDA
In FOOD SAFETY PLAN -> Supply chain program 

  • Another entity in the supply chain, such as a broker or distributor, can conduct supplier verification activities, but the receiving facility must review and assess that entity’s documentation that they verified the supplier’s control of the hazard.

Is this basically saying for distributor, we still need supply chain program for domestic suppliers as well? There is also FSVP talks about foreign suppliers only. 

I am trying to find references that saying as distributor, we still need supplier approval program for not only foreign suppliers but also domestic suppliers. Where is the reference about domestic suppliers need to have audit as well?

 

Also, below said foreign suppliers must have audit. 

eCFR :: 21 CFR 1.506 -- What foreign supplier verification and related activities must I conduct?

(i) Onsite audit of the foreign supplier.

(A) An onsite audit of a foreign supplier must be performed by a qualified auditor.

 

 

Please let me know if I am citing the correct reference about supplier approval program for domestic and foreign supplier 


Edited by nevin2756, 08 August 2022 - 08:51 PM.


ncwingnut

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Posted 09 August 2022 - 05:23 PM

Yes, as a distributor, you still have to have a supplier approval program.

 

We purchase from a lot of distributors - they in turn have to have vetted the supplier that they are wanting to provide product to us from, and provide documentation showing that this was completed.  We go by Supplier/Ingredient combo.  So for something we purchase from a distributor/broker we approve first the distributor, then the manufacturer if the ingredient they are wanting to supply us from.

 

I bet I made that clear as mud  :rofl2:



nevin2756

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Posted 09 August 2022 - 08:41 PM

Yes, as a distributor, you still have to have a supplier approval program.

 

We purchase from a lot of distributors - they in turn have to have vetted the supplier that they are wanting to provide product to us from, and provide documentation showing that this was completed.  We go by Supplier/Ingredient combo.  So for something we purchase from a distributor/broker we approve first the distributor, then the manufacturer if the ingredient they are wanting to supply us from.

 

I bet I made that clear as mud  :rofl2:

 

Do you have a regulatory reference about supplier approval program for domestic? Somehow, the people from my company thought approval for domestic suppliers is just BRC requirement. I am trying to show them it is also FDA not just BRC required.  :doh:


Edited by nevin2756, 09 August 2022 - 08:42 PM.


Bo16

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Posted 18 August 2022 - 04:12 PM

Agreed, as clear as mud when working with distributors.  Also, It's like herding cats to get an agreement as to who is the FSVP importer on records with many of our suppliers.  Sometimes it the distributor, sometimes the distributor will send it directly to us from a foreign supplier and I see they put us as the FSVP importer......  sometimes they admit it can be both them and us.  It makes it difficult to keep all the information together.  

 

Currently we are attempting to collect the same information regardless of FSVP importer.  

 

Oh, and to make sure we now have all the DUNs numbers.......  Keeps getting harder every year.



sqflady

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Posted 18 August 2022 - 07:46 PM

A supply chain program is required under the Food Safety Modernization Act and applies to all suppliers.  See 21 CFR 117 Subpart G.



nevin2756

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Posted 07 September 2022 - 03:15 PM

A supply chain program is required under the Food Safety Modernization Act and applies to all suppliers.  See 21 CFR 117 Subpart G.

This section mentioned about foreign suppliers verification. Does this subpart G also covers domestic suppliers as well? 






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