FDA requirement that 'sister divisions' to be treated as suppliers in 21 CFR 820

G

Gerry Quinn

#1
The FDA requires 'sister divisions' to be treated as suppliers in 21 CFR 820.
Does anyone have a process that they follow to perform the evaluation, selection, and monitoring of such suppliers? This is clearly defined in the preamble to the regulation.

100. 100. Several comments said that it was unclear what FDA meant by the phrase ``or held by other persons under contract conform to specifications’’ and that this phrase should be deleted. FDA agrees with the comments and has deleted the phrase. The phrase was intended to mean product and services, which were purchased or processed in some manner by other organizations. Section 820.50 now applies to ``purchased or otherwise received product and services'' to convey this meaning. FDA emphasizes that the requirements apply to all product and service received from outside of the finished device manufacturer, whether payment occurs or not. Thus, a manufacturer must comply with these provisions when it receives product or services from its ``sister facility'' or some other corporate or financial affiliate ``Otherwise received product'' would include ``customer supplied product’’ as in ISO 9001:1994, section 4.7, but would not apply to ``returned product'' from the customer.
 
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M

MIREGMGR

#2
Does anyone have a process that they follow to perform the evaluation, selection, and monitoring of such suppliers?
We have a major supplier that's also owned by our owner, though legally separate. We manage them exactly as if they were a completely independent company...we buy from them using P.O.s with specifications, we periodically send audit teams to verify that they generally operate according to their QMS and that their processes for us are operating as validated, and we verify that their products sold to us meet specifications as appropriate.
 
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