Questions and answers about FDA

  • FDA Hold Intact

    Question: Hello, I work for a Biotech company and our finished product is temperature controlled and we are looking at contingency plans for a potential FDA Hold.   If the product is not removed from its temp controlled packaging and moved into proper storage it could potentially cause an excursion and product could be invalided. Per […]

  • FDA Product Code and Intended Use Code determination

    Question: For all of you TC people in pharma and life sciences with product regulated by the FDA, who in your company makes the FDA Product Code and FDA Intended Use Code determinations.  This is being done by the TC team at my company but no has a science, biology or chemistry background and really […]

  • FDA Product Codes for importation into the USA

    Question: Are the Product Code, Intended Use Code and End Use Letter specific to the import process? Are these only required to be submitted by the importer or are these data points and documents required for domestic FDA filings and approvals? Are these part of the normal filing process between the FDA and the US […]

  • FDA End Use Letters

    Question: Hello, I work for an organization that has a couple of different products that are imported into the US by different brokers (legacy supply chain from companies acquired over time). One broker imports product without an FDA End Use letter and has been doing so for years while another broker insists that every shipment […]

  • FDA Officer Overreach of Authority and How to Resolve

    Question: I have a question about the authority of FDA officers. We have recently received some FDA refusals for a non-material error in the accession reports that were filed. These recent FDA refusals caused us to have to re-deliver the merchandise for re-export. I was told that CBP officers have the authority to handle the […]

  • Importing unapproved OTC R&D for human use

    Question: I’m looking to import an OTC drug product, already approved under an NDA, and I’m trying to import samples of the same product under a different brand, not approved in the US, not having an IND or other permit on file.  The samples will be used for human testing in a sensory test. The […]

  • FDA Legal Manufacturer vs Contract Manufacturer

    Question: Can someone help me understand what the is the correct FDA information to submit when importing products from a Contract manufacturer in which we are the design authority (legal manufacturer) but all manufacturing processes take place at the contract manufacturing facility in another country? My understanding is that we would use the Contract Manufacturer’s […]

  • FSVP

    Question: Is there a report we can run that will identify when we’ve been declared as the FSVP, but not the IOR? Answer 1: Currently the only way to get information on lines of entries in which you have been declared as the FSVP importer is to submit a FOIA request to FDA. We do […]

  • UC for FDA entries

    Question: My question is as it relates to the UC declared on the 7501 being subject to FSVP because we’ve had FSVP audits where we placed a domestic order and our vendor shipped directly to our US door.  As such, we were listed as the UC on our US vendor’s entry, and were flagged for […]

  • FDA Food import requirements question

    Question: FDA Food import requirements question – is there a way to import food samples without a Food Facility Registration number? I know Drugs and Medical Devices have a R&D intended use code you can use which does not require a manufacturer registration. Just wondering if this is also a possibility for food samples to […]

  • FDA Product Code Resource

    Question: Where can I find a resource that outlines each of the codes and their descriptions for industry, class, subclass, process indicator code, product, otherwise found in the FDA Product Code Builder? Answer 1: The lessons in the tutorials for the product code builder may be helpful. Here is the link: PCB Tutorial (fda.gov) Answered by: […]

  • FSVP Importer on DDP Shipments

    Question: Under a DDP transaction, can a foreign entity (shipping food items from Europe to the US) be designated as the importer of record on an entry for customs purposes and also designated as the FSVP importer for FDA purposes? Or does there need to be a US entity declared as the FSVP importer declared? […]