Questions and answers about FDA

  • 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? […]

  • FDA Holds

    Question: Recently, there was an import of perishable research samples under the FDA Memphis jurisdiction. Due to the intended use, there was no requirement to file any AOC data; only Roles information was needed. The shipment was imported, and the FDA issued a FDA Review, followed by an FDA Hold, and finally an FDA Intensive […]

  • FDA Import of Non-Regulated Medical Devices

    Question: Hello Members: My supply chain wishes to import Non-Regulated Medical Devices for the purpose of consolidating these Non-Regulated goods with other goods and than export so as to save on transportation cost.  I don’t think I can claim TIB (9813) for the import does not qualify.   I can’t use FDA Import For Export (IFE) […]

  • Manifest Hold Agriculture & FDA Memphis

    Question: Dear Members: Does anyone know what triggers a “Manifest Hold Agriculture”?  Broker could not explain why and submitted entry docs to CBP. Also, I am seeing a good amount of FDA Holds in the Memphis area when importing under headings 3002, 3822 and 9027. At a previous company we import headings 3002, 3822 and […]

  • Pharma Good Distribution Practices

    Question: Hello ICPA members.  My company is downsizing and consolidating roles.  My trade compliance function will be brought under supply chain and logistics.  It will be expanded to handle some OGA regulatory matters that are more supply chain than regulatory filings etc.  The role will involve leading the Good Distribution Practice efforts at our mfg […]