Antibiotic import from China


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Hello Everyone, I had a question in regard to importing antibiotics from a Chinese manufacturer who is not registered with the US FDA. The Chinese manufacturer notified us they do not want to ship antibiotics since they are not register with the FDA.

Our company will use the antibiotics within our culture media for our laboratory use only products and IVD products.

antibiotics and antimycotics are often added to cell culture media to help prevent the growth of contaminating bacteria, fungi, and mycoplasma.Can the antibiotics be seen as components to our products which would make it a component to our finished device products
Can anyone give me guidance on does our China manufacture or vendor who is shipping the antibiotics to USA need to be registered with the FDA And if there’s any other requirements?
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