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What is USFDA import alert?

What is USFDA import alert?
The Food and Drug Administration body (FDA) of the US is the main agency that administers wellness, health and safety of consumers by enforcing the Federal Food, Drug, and Cosmetic (FD&C) Act and other allied laws. The implemented laws hold true both in case of domestic and imported pharma products.

FDA imposes an import alert on any of the company without any prior notification that it considers has issues with product safety. The agency issues such an alert in the case when it considers it has sufficient proof in support of the products being unapproved by the authorities, adulterated or mis-branded. The drug manufacturers confront such import alerts on violation of laws and practices governing the manufacturing of pharma drugs.

Scope and Types of Import Alert

Several types of import alerts are issued for different product categories as well as their scope is huge. The products that are majorly impacted by import alerts include color additives,bakery items, active pharmaceutical ingredients (drugs), fruits and vegetables, cosmetics, bakery products, pesticide residues in foods, latex gloves among others. It is only in certain special cases that the import alert is issued against a particular company. The company also attracts the imposition of import alert in case it refuses the inspection of its manufacturing facility by the USFDA.

Impact of an Import Alert

Import alert on any company results in detention of its products at the border, which results in huge costs for its consumers. Some of the products in the import alert lists can still be imported but at an additional costs for the importer, which then reduces the amount the importer is willing to tender for the product. In severe circumstances, Customs department can be asked to seize the products of the company with import alert issue. The imposition of import alert hence costs substantial money, time as well as ruins the company' reputation and goodwill.


In a recent case, import alert has been imposed on Ranbaxy's Mohali facility. The USFDA levied the alert witnessing the violation of Current Good Manufacturing Practices (CGMP) by the company's plantn the town. The alert is said to be a major negative for the company as quoted by one of the brokerage firms.

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