Question: Two weeks we had a shipment that was held by FDA. We presented the goods to FDA and they seized the article in question. Now, this week we received notice of FDA action stating the entry of the good from 2 weeks ago, was refused and we need to present it for destruction. We […]
Question: Dear Members: I joined a new company and have been noticing that at times there are FDA holds or awaiting disposition for our perishable shipments (medical device). I have noticed that a product number was held for say 2 weeks. When I checked the same product number on previous entries, that same product number […]
Question: Company is looking to import various supplements for general health, skin care. What FDA requirements are there for these? Any other requirements. Think “natural” supplements for digestive health, etc.. Answer 1: FDA regulates both finished dietary supplement products and dietary ingredients. Good wbpages to visit are: https://www.fda.gov/food/dietary-supplements https://www.fda.gov/food/information-consumers-using-dietary-supplements/questions-and-answers-dietary-supplements https://www.fda.gov/consumers/consumer-updates/fda-101-dietary-supplements What is FDA’s role in […]
Question: Can you please let me know if FDA is required for chemical and biological compounds for research? These materials are for very early research and development. At that point these are toxins. These organic compounds or biological materials are for research that are not part of a clinical trial and that have not been […]
Question: For FDA regulated imports, what is the relationship between ACE and ITACS. Do you use them in conjunction with each other to better manage compliance for FDA regulated product? Is ITACS supplementary/complimentary to ACE or do these both need to be managed? Answer 1: ACE is used to transmit the entry data to FDA […]
Question: Can anyone provide me with guidance as to how the “AM7 – USDA/Agriculture Marketing Service data related to organics may be required” would apply to things like furniture, bathroom towels/bath mats, and rugs? I’m having a hard time understanding whether I should claim or disclaim this flag. Answer 1: It sounds like your classifications […]
Question: We are about to import diagnostic reagents (3822). These reagents get flagged for FD1 which is no disclaimed and proceed with entities role & AOC information. However, when I get flagged AQ1 and I have a Statement (Guideline 1121) saying products do not require an import permit. Because of statement can I disclaim AQ1? […]
Question: We have 3 medical devices that we send to Mexico for Kitting. These medical devices are not manufactured by us. One device is made in China, second device in Thailand and the third in the USA. All 3 devices have their own HTS classification. This kit is a set. Being new to the company […]
Question: If I am a USA Importer of medical devices, form 7501 Box 26 shows my IOR information. As for Box 25 (UC) would be same as box 26. What if I purchase the goods and tell the foreign manufacturer to ship the goods to another party. I would show the 7501 with my IOR […]
Question: If I am a USA Importer of medical devices, form 7501 Box 26 shows my IOR information. As for Box 25 (UC) would be same as box 26. What if I purchase the goods and tell the foreign manufacturer to ship the goods to another party. I would show the 7501 with my IOR […]
Question: Does anyone have a list of tariff codes that can be disclaimed for FDA? OR any link that provides the info? Asked by: ami mehta – ami.mehta@teradyne.com Answer 1: If you have access to ACE, look for an REF-001 report. Answer 2: Attached is a link to the FDA website. https://www.fda.gov/industry/import-basics/harmonized-tariff-schedule-and-fd-flags Answer 3: PGA […]
Question: Does the FDA allow for a self-disclosure, similar to the way CBP does? Can anyone point me to the FDA regs where it is detailed if in fact it is allowed? Answer 1: You want to be careful here and talk to you company’s legal counsel about this. You did not indicate if this […]
