VDmax25 and cGMP requirements for "research use only" products

#1
I am planning on injection molding some containers in China in a non-cGMP factory. I am then planning on shipping them to the USA for VDmax25 validation and e-beam sterilization. The products will be labeled as "for research use only." For the VDmax25 standard, is there a requirement that the injection molding company be cGMP compliant?
 
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#2
It is not necessary to be cGMP compliant but it will be good if the parts is molded in a controlled environment.
 
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