Troubled Fresenius Plant Upgraded by FDA

The FDA has upgraded its rating on Fresenius’ APP Pharmaceuticals New York plant, clearing the facility, which had been troubled by pest problems, to produce new drugs for Fresenius’ Kabi arm.

The plant, located in Grand Island, N.Y., was upgraded from official action indicated to voluntary action indicated. The FDA designates inspected facilities based on the quality observations it makes during inspection, with OAI being the most severe; VAI represents less significant quality problems.

Fresenius received the OAI status as the result of a 2012 warning letter that faulted the company for a litany of quality violations, including insects found in the manufacturing area during a 2011 inspection.

Fresenius was also chided for manufacturing unapproved prescription drugs. Fresenius did not elaborate on the changes it made to the facility to warrant the upgrade. But the company’s 2013 annual report shows that $42.5 million was paid in remediation costs at the Grand Island facility and a separate facility in Kalyani, India.

The India facility was warned in 2013 for serious data integrity violations, such as testing samples unofficially and not reporting all of the results obtained from those tests. Workers at the Kalyani plant also blended a batch of active pharmaceutical ingredient that had failed impurity tests with a batch that had passed in order to meet final impurity specifications, the letter says.

Fresenius did not return a request for comment by press time.

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