Fresenius awaiting FDA reinspection at plants in NY, India

Having racked up several warning letters over the past few years, Fresenius Kabi is now optimistic that two of its affected plants are getting back on track. Further progress is dependent on FDA inspectors visiting the plants in Grand Island, NY, and Kalyani, India, but with the agency dealing with failings at multiple companies, Fresenius thinks it might be a while before the regulator visits.

Fresenius Chairman Mark Schneider told investors the company has initiated the process by asking FDA to reinspect the Grand Island plant. When the agency will get around to visiting the plant is unclear, though. "We recognize that the compliance team at FDA is pretty busy right now," Schneider said. Given the uncertainty associated with the timelines of any remediation program, Fresenius has taken steps to protect its business from delays, notably by moving new products to other plants.

The strategy of changing the production plant for drugs that are awaiting approval means Fresenius expects its 2015 product launches to be unaffected by the status of Grand Island. Fresenius agreed to sell one of its U.S. production plants to Xellia Pharmaceuticals last month, but still has the Chicago plant that forms a cornerstone of its North American capacity. The Chicago plant has a good record in FDA inspections.

Fresenius also talked up its progress outside the U.S., with Schneider saying the Kalyani, India, plant savaged in an FDA warning letter last year is now shipping drugs to some markets. The site passed an inspection by the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) earlier this year and is now on the list of facilities awaiting re-inspection by the FDA.

AMRI ($AMRI) commented on the extent of industry noncompliance with GMPs on a conference call to discuss its second-quarter results, reports. "When you really think about the number of facilities owned by Big Pharma or even generic pharmas in the U.S. that are operating at a full compliance level, it's really relatively small," AMRI CEO William Marth said.

- here's the Fresenius transcript
- read Outsourcing-Pharma's article