The U.S. Food and Drug Administration (FDA) regulates a wide range of goods entering the United States. In fact, some would argue that they are even more active at the border than CBP.

When data is transmitted to FDA, it immediately enters a "Pending FDA Review" status. It is neither released nor held, it is merely pending review, which might take up to 48 hours. More commonly, the disposition of "May Proceed" or "Hold Intact" will be issued within a couple hours, sometimes sooner.

While under review, the cargo may be picked up, but must remain in the vicinity of the port. The "vicinity" isn't clearly defined, but a good rule of thumb is 30 to 50 miles. If a "Hold Intact" message is issued, set it aside in your warehouse and don't touch. The INLT Inc. operations team will preemptively upload your documents to FDA's ITACS system and FDA field officers are likely to schedule a visit to examine the product.

Make sure "PGA Released" is activated in your notification preferences here to ensure you receive an email when the "May Proceed" is issued.

If you have any questions concerning this process, please contact for assistance.

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