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US FDA warns Fresenius on drug manufacturing violations at India plant

The U.S. Food and Drug Administration warned Fresenius SE & Co. KGaA on violations of drug manufacturing regulations at a plant in India.

The warning came after the company's drug manufacturing facility in West Bengal, India aborted 248 drug-quality tests, according to the regulators' warning letter to the company dated Dec. 4.

The facility is run by the company's unit Fresenius Kabi Oncology Ltd.

According to the FDA's warning letter, the company did not use adequate out-of-specification procedures and lacked scientific justification to invalidate initial out-of-specification results. The term out-of-specification results includes all test results that fall outside the specifications or acceptance criteria.

The FDA recommended that the company hire a consultant to help it improve its manufacturing practices. The agency also asked Fresenius to review all failed quality tests that were invalidated for products that are meant to be sold in the U.S.

In addition, the regulator asked the company to evaluate all instances when a test was interrupted or aborted and determine the potential effect on the quality of active pharmaceutical ingredients released for distribution.

The FDA also warned that if the company does not correct all violations completely, it may withhold approval of any new applications or supplements listing the firm as a drug manufacturer.