FDA accuses manufacturer of ignoring quality control tests

Jan. 4, 2018

The U.S. Food and Drug Administration says that workers at an Indian plant owned by Fresenius SE ignored sterility tests that showed its products could contain impurities.

According to Bloomberg, the FDA issued a letter on Dec. 18 saying that workers at the plant, located in Baddi, India, repeatedly invalidated tests showing that the drugs could be contaminated. The facility manufacturers cancer drugs, but the FDA did not specify which products specifically were involved.          

The investigation stemmed from a January 2017 incident showing that some of the medications tested positive for possible bacteria contamination, but the practice of tampering with lab results reportedly dates back to 2015. Employees at the facility blamed testing errors for the positive contamination results.

Fresenius stated that it doesn’t expect any supply shortages to stem from the investigation. The FDA recommended that the company work with a consultant to improve its testing and reporting practices.

Read the Bloomberg coverage