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FDA Removes Import Alert for Basmati Rice from India

On February 19, 2016, the U.S. Food and Drug Administration (FDA) removed Import Alert 02-01, “Detention Without Physical Examination of White or Brown Basmati Rice From India”.  Registrar Corp was alerted of the removal by the FDA Compliance Monitor.  Before the alert was removed, all basmati rice shipped from India was subject to Detention Without Physical Examination (DWPE) upon arrival to the United States unless the importer was on the Green List.

A Green List identifies companies that have proven to FDA that their products are compliant with FDA regulations and are therefore exempt from a particular Import Alert.  There were 62 facilities on the Green List for Import Alert 02-01.

Why did FDA create the Import Alert originally?

FDA inspected 34 shipments of basmati rice from India between December 1986 and May 1987 and found that 73 percent of the shipments were contaminated with filth. When the problem persisted, FDA created Import Alert 02-01.

Now that the alert has been removed, basmati rice shipped from India will be subject to the routine import process.  This means that shipments may be stopped for randomized inspections, but will not be stopped every time they are shipped and will not be detained unless an inspection reveals compliance issues.

There are still 253 active FDA Import Alerts that subject certain products to DWPE.  Facilities are often unaware that their products are on Import Alert until they are detained at the U.S. border. This is especially true for country-wide import alerts such as 02-01, which encompass all exporters despite their compliance history.  For example, Import Alert 24-11 subjects all dried peppers from Mexico to DWPE. A Mexican exporter just entering the market with no history of compliance issues could find his shipments detained under the alert.

Facilities can check whether they are subject to an FDA Import Alert using Registrar Corp’s FDA Compliance Monitor.  For facilities that find themselves on Import Alert, Registrar Corp can help petition FDA for exemption. For more information about FDA Import Alerts or Registrar Corp’s services, contact +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

 





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