The U.S. Food and Drug Administration (FDA) slapped the pharmaceutical company Novartis AG with a warning over drug manufacturing violations. The Swiss drug-making giant was hit with the warning last week regarding problems found at two of its India-based plants last year.
The FDA inspected Novartis' western India plants in Kalwa and Turbhe in August 2014, but the regulator did not formally issue the warning to Novartis's Sandoz unit until Oct. 22. The FDA says that it first expressed its worries to Novartis last year and the pharmaceutical manufacturer has been trying to resolve them ever since.
Specifics on the Warning Have Not Been Released
Novartis has not indicated the specifics of the warning, and the FDA has yet to publish the warning letter on its website.
Novartis issued a formal statement in response to the warning, saying that "Sandoz will continue to work closely with the FDA to ensure all observations are resolved to the agency's full satisfaction." Novartis does not expect the issue to affect its ability to supply its distribution chains.
Numerous Indian-Made Drugs Already Banned
The FDA has increased the frequency and exactness of inspections at foreign drug manufacturing facilities in recent years. Some of India's biggest drug makers, which supply generic equivalents to name-brand drugs, have been rebuked. The FDA has already banned drugs from 30 Indian-based pharmaceutical plants since 2013.
In response to the FDA's warnings, Novartis announced in July 2014 that it will be closing its Turbhe facility, where it manufactures pharmaceutical ingredients and antibiotics, before December 2015. Meanwhile, Novartis CEO Joe Jimenez, said last Tuesday that the Kalwa site has already been brought up to speed.
Consumers hurt by dangerous and defective pharmaceutical drugs can seek financial restitution for their injuries in court. Personal injury litigation regarding injuries or deaths caused by defective drugs falls under the category of product liability law.
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