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Tags: FDA, Import

Need to Improve FDA Import Data

February 1, 2016

Customer Service

Most foreign shippers are aware that specific documentation requirements such as commercial invoice and the use of appropriate Harmonized Tariff Schedule (HTS) codes are required for a commercial shipment to enter the United States from abroad. When an import shipment is regulated by the Food and Drug Administration (FDA), additional data elements can make the completion of required documentation challenging for outsiders. Some elements, which are proprietary and issued to manufacturers and importers for each commodity, are extremely important to the quality of the import information.

  • The FDA released Letters to Industry to specify recommended import data elements, such as FDA product code, Affirmation of Compliance (AofC) elements, and company/manufacturer details.
  • The importance of complete and thorough data submission is often underestimated by shippers. Even though some of the AofC data elements are only labeled as “voluntary,” the FDA PREDICT import clearance system will not grant automated clearance of safe and compliant shipment unless AofC data elements matching FDA databases are provided.
  • Missing or incorrect FDA import data elements typically add significant FDA review time for a shipment to enter the US, while FDA staff, brokers and importer resources attempt to obtain all the required additional information. As a result, your FedEx Express shipment could be delayed by at least one day because your shipment may not make its planned connecting flight within the FedEx network.
  • The time frame of the subsequent FDA review is affected by the commodities, FDA staffing level, and FDA hours of operation.

A pilot program called Centralized Entry Review (CER) provided insights into the operational impact of incomplete and inaccurate paperwork. FedEx Express took part in the CER program, which was limited to express couriers, 6 FDA import districts, and 14 ports of entry. Import workload shared among all selected import districts and extended FDA hours of operations characterized the 49-day program tested in 2013. Results of the CER pilot program were not widely communicated, but included interesting findings about import delays. Submitted FDA product codes were found to be wrong 40% of the time! A major improvement is certainly needed around data quality, in particular for healthcare shipments.

FedEx Express offers complimentary advice to increase the likelihood of experiencing an immediate FDA release at its six US FedEx ports of entry. Shippers who contact the FedEx Regulatory Consulting Group prior to shipping can obtain feedback on abbreviations, acronyms, terminology, and syntax listed on shipping documents.

Christelle Laot

Technical Fellow

Dr. Christelle Laot joined FedEx Express in 2007, and is currently Technical Fellow in the FedEx healthcare industry vertical. In this role, she provides direction and raises awareness around trends, transportation regulatory frameworks and shipping solutions. Prior to her work with FedEx, Dr. Laot held managerial positions in R&D, innovation and strategy at Bayer in Germany for about six years.

Dr. Laot obtained PhD and MS in Chemical Engineering from Virginia Tech (USA), a Diplôme d’Ingénieur from UTC Compiègne (France), as well as an MBA from HEC Montreal (Canada).

View all Christelle Laot’s blog posts

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