Question: Problem: approx 33 percent of shipments being checked / held by FDA. exporter: FDA registered OEM of medical devices (stents) in Germany Consignee`s all over USA with different import know how, partly C-TPAT certified. Incoterms: 90 % EXW and 10 % DDP named place of destinations. Incoterms could be switched […]
Question: We have instances where the Customs country of origin and FDA manufacturing site are in two different countries. For example, a part is made in Germany, but then sent to the US for final processing into a finished medical device – final processing in the second country only includes sterilizing and packaging […]
Question: Has anyone seen it make a difference if a CNCA certified manufacturer is NOT used? Or is this just something nice to have? Does it make any difference CNCA certified and CCIB marking as the FDA “strongly urges”? Please help. The FDA states the following: Importers Strongly Urged to Ensure that “Daily-Use” Ceramic […]
Question: If we need to ship EAR99 medical/dental supplies to Afghanistan for use by US forces, are there any FDA export restrictions? (Examples: IV drip bag stands, metal scrapers, picks, etc. used in dental work, drip lines, plastic breathing tubes, fabric surgical drape cloths.) ============
Question:I have a really odd issue and hope the members can offer guidance…. 1 entry with 3 lines…..3 lines of completely different products ( 3 very different food stuffs ) line 1 detained as product was found to be from a producer on Import Alert 99-08line 2 status on NOA = pending FDA reviewline 3 […]
Question:Has anyone in the Pharma/Biotech/Medical device industry seen an increase in FDA Holds?
Question:I work for an importer/exporter of industrial lifting equipment. Upon import, some of our goods are flagged for potential FDA reporting. We do import some products with lasers, leds and radiation emitting products. Is there a worksheet that someone would be willing to share as to how they determine if the product needs an FDA […]
Question:Regarding Marking Requirements with a Twist (for CBP and FDA Purposes) I work for a USA company. Recently our Canada office placed an order with our Mexico office (bear in mind the USA is not involved in the transaction). The Canada office purchases some bulk foodstuff from Mexico and asks Mexico to ship to a […]
Question: We have been trying to import a few different types of products that havebeen flagged FD2 by the FDA based on the product’s Harmonized Tariff Schedulecode. All of our products are intended for “Research Use Only” (as we are a Biotechcompany) and should not be regulated by the FDA. Because of the FD2 Flag,our […]
Question:We have been trying to import a few different types of products that have been flagged FD2 by the FDA based on the product’s Harmonized Tariff Schedule code. All of our products are intended for “Research Use Only” (as we are a Biotech company) and should not be regulated by the FDA. Because of the […]
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 firing on […]
Question: Do most that work in the area of importing investigational drug products deal with their Regulatory Project Manager assigned by the FDA to the specific IND in regards to assistance with detailed import/export questions or to another specific contact? Any agency specific contacts outside of the typical CDER Drug Information Specialists would be greatly […]
