Original Question: Am seeing increase in FDA inspections & holds. My customs broker tells me he’s seeing it across the board and we are not being singled out. Through rumor mill I’m told part of the reason is FDA’s fiscal year starts Oct 1 and now that they have the budget for lab/inspection they are […]
Question: Does anyone have a list or know on the FDA website where a list can befound of independent laboratories approved by FDA?
Question: We are an importer of surgical apparel which can be either a class I or class II medical device depending upon the item. The HTSUSA’s for these goods are apparel classifications, “other, other” and have NO FDA code at all – no FD0, nothing. I have queried the HTS numbers in our ABI […]
Question: We were asked by a supplier to provide an End User Letter for a product regulated by the FDA. I have heard of EULs for exports but not for imports. We used to be the IOR but a decision was made by buyers and procurement to purchase the product domestically. The current […]
As most of us know sometimes government agencies have different definitions for the same required data. We all know that the CBP definition of MID is the “invoicing party”. But for FDA purposes, can anyone share FDA written instructions on the FDA definitions for: FDA MID FDA SID We feel that the FDA MID is […]
Our company imported an FDA regulated product which we often import. We missed a deadline to submit a request for information by FDA. They have now refused the entry and requested redelivery of the product or the product be destroyed. Now the real problem…this product was never released by FDA and we have already distributed […]
There is some verbiage that goes along with the FDA 2877 form for importing computer monitors, not being subject to radiation standards because of : ______________________________? I have the info for Oscilloscopes, but cannot find my info on CRTs’? Do you have that?
My legal department is having a risk assessment debate on the possible sale of one of our products to the medical field. Their concern was that, if the product was involved in a medical injury, the FDA could order a halt to the sales. The attorneys then started going off on the possibility of the […]
One of our subsidiaries imports pet treats made with chicken. The manufacturer is registered with the FDA, we have a license and a vet certificate as the documents are not a problem. However almost all containers with the chicken flavored pet treats are being held by the FDA for inspection while beef treats are not […]
My company employees several Japanese citizens on ex-pat assignments at our US facilities. One of the benefits extended to these employees is the ability to order Japanese foods from a vendor in Japan who will ship their orders to them at company expense. Our standard policy is that the ship-to must be the home address […]
I have been searching the FDA website for information regarding importation of ceramic/porcelain bathroom tumblers to determine if FDA is required. Has anyone in the group had experience with importing this type of item and, if so, did they declare the item to FDA?
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?
