FDA Detaining Shipment Due to Non-Registration and Missing Drop Ball.. What to Do?

[kashacin]

I run a fashion eyewear retail and very recently received a shipment of 2000 pieces of fashion sunglasses from a manufacturer in China.

After shipment went through customs, FDA reached out to my customs broker, saying that the shipment is "detained" due neither my business nor the manufacturer being registered w/ the FDA and there being no drop ball test for the shipment (the lenses are AC).

I actually sent my customs broker the drop ball test and the manufacturer's registration information... Either she forgot to send it to them or the FDA is not accepting my manufacturer's registration and drop ball test (I'm emailing my customs broker now to make sure she sent it). I'm worried that my manufacturer's registration w/ the FDA is not current.

Today, the FDA returned a notice saying that I have 30 days to let them know how the shipment will be "brought into compliance".

I am not sure what they're asking for aside from providing a drop ball test.

Anyone familiar with situations like this? Any insight would be helpful.

Thank you, everyone.

[DocInChina]

Both your company as the importer and the manufacturer need to be registered with the FDA. Additionally, when the manufacturer registered they needed to register the products that they were going to export to the US and your company when registering also needs to register the classification of products you are importing into the US. Registration costs for 2020 are $5,236/company.