My company is currently reviewing its policy with regard to assisting our foreign suppliers with their FDA Facility Registration. Is anyone willing to share their company’s policy? Is anyone supplying a list of possible U.S. Agents to assist with this process, if so, would you be willing to share it?
Has anyone heard about a bill before Congress that could assess up to $1000 per line item fee on Entry items of FDA classified goods?
You have to review the product to determine if it is regulated by the FDA. See FDA’s website for more details – they have examples of the types of products they cover. Some HTS#’s come up for FDA1 regardless, such as AGR items, so you have to research by the nature of the product. Your […]
I was instructed by my broker that the FDA product code I had instructed them to use was not valid. I went ot the FDA product code builder on the web and was able to create the FDA product code I had instructed my broker to use. I than did a key word search on […]
Does anyone have any information on general FDA or does anyone know of an FDA training course to attend in 2008? I’m just looking for some answers to general questions. For example, using the product code builder we know that Griddles are specifically provided for, but what about parts of the griddle? If we started […]
Does every FDA regulated registered product, having an acession number, require an FDA 2877 be filed when imported into the US?
We purchased a cord blood bank company last year with the expectation all blood will originate from the United States. There is an opportunity to bank blood from outside of the U.S. and we are researching the various regulatory requirements with the Department of Health, Food and Drug and Customs to import cord blood. We […]
