Question: My broker tells me I need to file a FDA 510K. Never heard of the critter. Can’t say that I especially want to. But, it looks like I need to hear about this thing need to. And the answers database comes back with a Zero. So, here are my questions: 1 […]
Question: We’ve noticed a recent increase in FDA (food) exams on cargo arriving via the port of New York. Across the board on different products ( fruits to vegetables ) and different origins ( Europe, South America etc). Am curious to know if the membership is also seeing an increase. I know PREDICT is being […]
Question:Among the things I value in being a member of the ICPA is the community of practice established in reaching out to ask questions…even the embarrassing ones. With all the hoopla about the FDA’s Transparency Taskforce…I’m curious to know if I’m missing something or if I simply haven’t clicked the right link. As a responsible […]
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 […]
