How to avoid the lengthy FDA holds

22 May, 2010 by  Kent Thorup

When importing pharmaceutical materials and compounds into the USA, we all (carriers and importers alike) have experienced the frustration of unexpected and sometimes lengthy FDA holds. While it's impossible to avoid the inspection process, there are things that an importer and shipper can do to reduce the risk of a significant delay.


First and foremost, make sure the import documentation submitted for US import is complete and accurate. Depending on the actual contents, the paperwork process can be tedious and therefore it's easy to leave out an important piece of information or documentation. As an example, some important items that you'll want to include with your shipment are: 1) Commercial invoice (triplicate copies) to include IND#. 2) A declaration of "End Use" which describes the exact purpose of the materials and their eventual disposal. 3) If available, Chemical Analysis Screening (CAS).

For a complete list of items needed for CBP/FDA import, go to:

By the way, advance review of import/export documents is part of our normal procedure at QuickSTAT. Vendors and Service Partners

Choose a reputable courier and customs broker with years of experience in handling pharmaceutical compounds and biologics -- these are your most important resources for ensuring smooth import/export. Communication is the key - always discuss your shipment with your courier and/or broker before shipping.

Packaging Material

The shipper should make sure a well-tested transport container (cooler) is used when importing temperature sensitive pharmaceutical compounds. An experienced specialty courier like QuickSTAT will work diligently to keep the shipment's coolant replenished during transport and customs clearance, but it never hurts to add plenty of coolant at the front end in the event a significant, unforeseen delay should occur.  Responding to FDA holds

When a FDA hold occurs, the importer of record is contacted directly by the FDA - therefore, it's important for shipper and importer compliance officers to be acutely aware when a shipment is expected so they can be prepared to quickly respond to an FDA inquiry. In most cases, the FDA hold lasts about 24-48 hours - but can go on for weeks, even months if the FDA's initial request for information does not receive an immediate and complete response. 

Logistics Tips:   Classifying Biological Substances as Dangerous Goods
Easy to follow guide on how to classify biological commodities for transport as dangerous goods:

  - 5 common classification scenarios 
  - easy to follow guidelines
  - overview of dangerous goods regulations

About Kent Thorup
Regional VP

Kent Thorup, Regional Vice President of Business Development for the Quick Group of Companies, has over 38 years of experience in global logistics planning for time-critical, temperature-sensitive and urgent materials. He... Read more.

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