FDA: Drugmaker ignored bad quality tests in India

U.S. regulators have sent a warning letter to Fresenius, after the company’s plant in India, which makes cancer-drug ingredients for the U.S. market, aborted hundreds of drugquality tests because it seemed they were going to fail due to impurities.

When workers at the plant found potentially tainted products, they halted the tests and said human or machine errors were to blame instead, according to a Food and Drug Administration warning letter dated Dec. 4 that cited 248 aborted checks at the West Bengal facility.

“It is essential that you initiate an immediate and comprehensive assessment of your company’s global manufacturing operations to ensure that systems and processes, and ultimately, the products manufactured, conform to FDA requirements at all your sites,” the agency said in its letter, which was posted on Tuesday.

The agency recommended that Fresenius hire a consultant to help it improve its manufacturing practices. The company, based in Bad Homburg, Germany, didn’t respond to requests seeking comments.

The names of the ingredients involved were redacted in the FDA letter. may have cost the company hundreds of millions of dollars and has drawn criticism for exploiting drivers who have bad or non-existant credit histories.

The auto- lending unit, Xchange, is set to be purchased for an undisclosed amount by Fair, a car lending start- up, according to the Wall Street Journal.

Experts say the move signals a more disciplined, cost- cutting approach by newly installed chief executive Dara Khosrowshahi, who is aiming to take the ride-sharing company public within the next two years and is vying to repair Uber’s relationship with its drivers and the public.

The auto loans offered by Xchange were designed to attract new drivers to Uber.