Drugmaker Warned Again for Ignoring Bad Quality Tests

(Bloomberg) -- U.S. regulators warned Fresenius SE last month that workers in one of its cancer-drug plants ignored tests that found the products made there weren’t meeting sterility standards.

Manufacturing tests are used to make sure drugs are sterile and free of contaminants. At Fresenius’s Baddi, India, facility workers had a history of invalidating the quality tests when a negative result was found, the Food and Drug Administration said in a Dec. 18 warning letter to the company.

The FDA said the practice dated back to at least 2015. The warning letter about the Baddi plant follows a Dec. 4 letter the FDA sent to Fresenius about a different West Bengal Fresenius plant where workers aborted hundreds of drug-quality tests because they seemed like they were going to fail due to impurities.

At the Baddi plant, FDA investigators outlined a January 2017 test by the company’s workers that drew particular concern because of bacterial contamination. The workers at the plant said that a laboratory testing error was the problem, not contamination.

Company Cooperating

Fresenius shares were down 1.1 percent to 64.36 euros at the close in Frankfurt. The company is “fully cooperating with the FDA,” Matthias Link, a spokesman for Bad Homburg, Germany-based Fresenius, said in an email.

“We have worked intensively on corrective and preventative actions and have already made improvements to the procedures and documentation processes in both plants,” Link said.

Fresenius doesn’t expect a supply shortage of the products it sends to the U.S., and doesn’t expect a material financial impact because of the warnings, Link said. The warning letters didn’t specify which products are made at the plants.

The FDA said the company had failed to adequately investigate potential manufacturing causes of the problems. Given the repeated failure to fully investigate, despite Fresenius offering to make fixes when FDA initially found violations in 2015, FDA investigators said “your facility’s oversight and control over the manufacture of drugs remains deficient.”

The agency recommended Fresenius hire a consultant to help it meet manufacturing standards and noted the Bad Homburg, Germany-based company’s executive management “remains responsible for fully resolving all deficiencies.”

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