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Changing Non-Critical Component Suppliers - Convenience kits (FDA) Procedure packs
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Changing Non-Critical Component Suppliers - Convenience kits (FDA) Procedure packs
Changing Non-Critical Component Suppliers - Convenience kits (FDA) Procedure packs
Changing Non-Critical Component Suppliers - Convenience kits (FDA) Procedure packs
Changing Non-Critical Component Suppliers - Convenience kits (FDA) Procedure packs
Changing Non-Critical Component Suppliers - Convenience kits (FDA) Procedure packs
Changing Non-Critical Component Suppliers - Convenience kits (FDA) Procedure packs
Changing Non-Critical Component Suppliers - Convenience kits (FDA) Procedure packs
Changing Non-Critical Component Suppliers - Convenience kits (FDA) Procedure packs
Changing Non-Critical Component Suppliers - Convenience kits (FDA) Procedure packs
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Changing Non-Critical Component Suppliers - Convenience kits (FDA) Procedure packs


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Some Related Topic Tags
convenience kits (medical device), fda (food and drug administration), mdd (medical device directive)
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  Post Number #1  
Old 31st July 2009, 12:02 PM
Gumaer

 
 
Total Posts: 10
Please Help! Changing Non-Critical Component Suppliers - Convenience kits (FDA) Procedure packs

My company assembles convenience kits (FDA) / procedure packs (MDD). If the customer specification simply says 4.5 oz PP cup (used for urine collection), would changing the supplier of the cup (like for like) be considered a specification change?

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  Post Number #2  
Old 31st July 2009, 11:34 PM
MIREGMGR

 
 
Total Posts: 3,685
Re: Changing Non-Critical Component Suppliers - Convenience kits (FDA) Procedure pack

If the spec is that vague, you probably erred in accepting the PO without clarification.

Who called out the original (at time of PO) vendors?

If the customer, the vendor selections are an implied spec as well.

If the PO does not explicitly include in its definition of your directed actions the determination of vendors and the determination of whether alternate components are in fact "like-for-like", you are in the position of having to get the customer's approval for any vendor change or component substitution.

Contract review is all-important in avoiding questions like this.
  Post Number #3  
Old 12th July 2010, 04:39 AM
taha3000

 
 
Total Posts: 1
Re: Changing Non-Critical Component Suppliers - Convenience kits (FDA) Procedure pack

Dear Colleague

what are the FDA guidance for convience kit or procedure packs.


regards


Taha
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