FDA

QUESTION: We have a situation where our foreign vendor imports into a bonded warehouse (which is run by a 3PL) and we withdraw product as needed. We are not their only customer that withdraws from this bonded warehouse. The products we withdraw, for our purposes, are FDA regulated.  As I understand the requirements, any FDA […]

QUESTION: If Corporation A owns Divisions 1, 2, and 3 and Divisions 1, 2, and 3 import goods is it compliant for Corporation A to be declared as Device Initial Importer for the shipments imported by Divisions 1, 2, and 3? ========== Answers: There is some details missing here thus I’m making some assumptions in […]

QUESTION: FDA recently initiated FDA filing requirements for non-medical LED products. Unfortunately, the tariffs are not yet flagged for FDA but we are still being required to file the FDA info.   How are you / your broker reporting?   Also, would you think just one LED is reportable? ========== Answers: LED lights can be […]

QUESTION: Our company imports 100’s of raw materials needed to manufacture FDA Regulated Medical Devices. Many of the raw materials 7have HTS numbers that do not flag for FDA, and are items that would not normally be under FDA’s authority, such as air or liquid pumps, stepper motors, aluminum or steel cabinet panels and brackets. […]

QUESTION: I was told by our customs broker that new Regulations are in effect by the FDA on 2/2 impacting items classified under HTS: 8541.20.2000. I was told that this HTS will require FDA filing?  Has anyone heard/read anything about it?  I can’t validate this information to implement such changes. ========== Answers: I am having […]

QUESTION: I am interested to import food product which is subject to FDA oversight.  What CBP issues do I need to understand?  What FDA and/or other government agency regs do I need to be aware of and comply with?  Can you suggest any good reading material to get up to speed on regulatory matters regarding […]

QUESTION: We are a pharma company in development of a new investigational drug.  We manufacture the API outside the U.S. and turn it into finished product inside the U.S.  We would like to import an entire batch of API for finishing, use part of the finished drug product in pursuance of an IND (testing, evaluation, […]

QUESTION: My company is importing components and assemblies for medical goods. We are providing the following information: Program Code:  DEV Intended Usage Code:  081.007 We’ve been able to work out the Affirmations of Compliance, however, the Gov’t Agency Processing Code for RED / NED determination has been a challenge for the analyst. Is the FDA […]

QUESTION: Does ACE allow for corrections to be made to FDA filing?   Two situations have been caught in an audit and I am wondering what recourse exists: 1)       FDA Claim – wrong FDA product code or other Mandatory elements filed. Can a correction be made to input the correct mandatory elements? 2)      FDA Disclaim […]

Question: Can someone find a reg and cite it defining the FDA country of origin? The question being, does packaging contribute to the automated country of origin declaration upon import? It isn’t black or white on their website. ========== Answer: Assuming you mean the outside packaging to support it for sale on retail shelves (bottles, […]

Question: It appears on October 10, 2003, FDA issued an interim final rule to implement amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), which requires domestic and foreign facilities that manufacture, process, pack, or hold food […]