FDA smacks third Alkem plant with Form 483

FDA
FDA inspectors have found issues with a third Alkem facility.

FDA inspectors began rolling through the plants of India’s Alkem Laboratories last year after being alerted to problems by U.K. regulators, and they have now found issues with a third Alkem facility.

In a public filing, the drugmaker said the FDA had issued three observations to the facility in Badi following an inspection that concluded Friday. The drugmaker provided no details on the citations but said it had put together a corrective action plan.

The citations followed regulatory actions against an Alkem plant in Gujarat in December, which also received three observations, and one taken last September for a plant in Daman that was slapped with 13 observations.

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Earlier in 2016, U.K.'s Medicines and Healthcare Products Regulatory Agency said an inspection of the company's Alkem’s Taloja site found instances of data falsification.

But problems with Alkem are not new to the FDA. In 2014, it sent U.S. marshals into a warehouse in Ohio to seize more than $11 million worth of drugs made by Alkem subsidiary Ascend Laboratories, including skin creams, ear drops and a treatment for inflamed hemorrhoids. It accused Alkem Laboratories of selling the products in the U.S. without ever getting approvals for them and said it had repeatedly warned the drugmaker it needed approvals following an inspection.

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