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Regulatory Focus™ > News Articles > FDA Bans Drugs Made by Indian Manufacturer Over GMP Problems

FDA Bans Drugs Made by Indian Manufacturer Over GMP Problems

Posted 23 January 2015 | By Alexander Gaffney, RAC

US medicines regulators have quietly banned drugs manufactured at a facility owned by Ipca Laboratories, an Indian pharmaceutical manufacturer, from entering into the US after finding that its products were not manufactured to federal standards.

On Thursday, 22 January 2015 the US Food and Drug Administration (FDA) issued an update to its Import Alert 66-40, which is used to warn US customs officials that a company's products have not met good manufacturing practices (GMPs) for pharmaceuticals. The import alert usually follows a physical inspection of a facility by FDA officials.

Ipca Pharma Import Alert

The issue of an import alert is almost always followed by a Warning Letter indicating the extent of the problems at the facility. For example, a Chinese company was placed on import alert in July 2014 following an inspection. In September 2014, FDA issued a Warning Letter to the company accusing it of having purchased raw materials from companies linked to an earlier scandal.

In a statement to Reuters, Ipca said it had halted shipments of drugs from the facility since July 2014 after FDA regulators identified a slew of potential GMP violations.

Ipca is not alone in its GMP problems. According to data compiled by Regulatory Focus, at least 13 other Indian manufacturers have been subject to Warning Letters from FDA since May 2013. All 13 of those letters have cited irregularities with the companies' data integrity practices. Not all have been subject to import alerts, however.


FDA Import Alert List (List Constantly Updated)

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