FDA regulations on sauce packs in product

I have the worst time navigating the FDA website.  So, if anyone could help, I'd really appreciate it.

I was just informed today that our parent company wants to add a sealed sauce pack to our RTE product (imitation crab legs), then ship it to the US for us to distribute and sell.

The sauce will have the same, or longer, Best By Date, ingredients will be listed, net weights declared, etc.  

What else would be needed?

I think you've got the bases covered with what you listed, making sure there's any necessary allergen declarations on this sauce (if applicable).

One possible gap to investigate is how the sauce packets are handled prior to insertion with your RTE product.  We had an argument with one of our plants where they're adding a dip container to RTE vegetable packs, as we QA asked them to dip the packets in a sanitizer bath prior to adding it to the finished container.  Reasoning is that when most manufacturers get to their finish step, GMP handling is lessened.  If you can get a HACCP plan from the sauce maker that they handle the finished sauce pouches in a way that makes them safe to contact RTE foods, that'd be great.  If not, we have to assume they're being handled like most other finished packages and in less than perfectly sterile manner, which presents a risk to your RTE product.

I'd want some sort of documentation on the film for the sauce packet to ensure it ok for food contact, assuming you haven't done so already.  I understand that the packet already has sauce in it, but I'd want assurances now that the outside of the packet is now handled in a way that means it would still be ok to be food contact.  I have seen to many placed that once a packet is produced is thrown into cardboard totes, dropped on the floor, etc.  Not sure if that helps.

I know that this might be an obvious point but ensure the addition of the sauce pack is in the HACCP plan, Flow Chart and Hazard Analysis.

This would help to support any questions of product contamination from storage, transport, and facility handling, plus can support you by having the product packaged at the processor, to ensure that sanitary condition is maintained. You do not want this to be considered as a possible source of adulteration/allergen to this or other products for cross contamination to your product.