1 reply to this topic

[JaylaJohnson]

Hi all. If we have a supplier that does not make the product (ex. receives product in bead form and grinds into powder form), do we only need to conduct risk assessment for the supplier (i.e. ensure metal from grinder is controlled for) and assume that they have conducted their own assessment, or would we need to seek out documentation about the original manufacture to uncover and control for other risks (i.e. chemical, micro)? Please provide any links from the FDA regarding our responsibility here.

 

Thanks!

[Tony-C]

Hi JaylaJohnson,

 

Verification activities will depend on the hazard and if it is controlled at your facility or the supplier or the supplier's supplier.

 

See §117.430 Conducting supplier verification activities for raw materials and other ingredients

"when a hazard in a raw material or other ingredient will be controlled by the supplier and is one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans …. etc"

 

Kind regards,

 

Tony