Question: I would like to ask the membership for those who have knowledge and or participating in an FTZ in which the imports are applicable to FDA. From my understanding, under an FTZ, one entry is completed per week. What happens if and/or when FDA places a hold on a particular item? Does the entry […]
Question: Can anyone advise of their current best practice under this scenario? Customers are requesting the FDA registration number for overseas food/drug manufacturing facilities. We believe that this information should be kept confidential inasmuch as there is no “public” list available from the FDA on the facility registration numbers. As we are the importer of […]
Question: My company is importing alcohol hand sanitizer under code 3824.90.9290 based on several binding rulings on CROSS. We are attempting to make entry for our first shipment. The HTS is flagging prior notice. I’ve provided the NDC and foreign facility identifier number for the manufacturer. FDA is requesting an 11 digit number for the […]
Question: A shipment was flagged for FDA docs required and broker did not submit the docs. FDA is looking for the freight. The goods have been distributed to retail stores for sale. Does anyone have experience with this and what is the range of action FDA could impose on penalties? ========== Answer: Yes, you are […]
Question: Our customer purchases our food products in the US, consolidates them and exports them to their food stores overseas. The same customer is now interested in purchasing products from Mexico that have Spanish labeling. They would like to import the Mexican products into the US and then consolidate them for export with US-labeled foods. They are […]
Question: I was wondering if anyone has come across this before where a label is required to be placed on the outer packaging for imports into the US with the statement “Caution: For manufacturing, processing, or repacking in the preparation of a new drug limited by Federal law to investigational use”. Apparently FDA in Tampa, […]
QUESTION: Can anyone in the pharma industry share examples of the different types of end use letters they use to import biologics, clinical trial, R&D and/or commercial product into the US? **************
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 […]
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.) ============
