The US Food and Drug Administration (FDA) observed management and staff manipulating quality control data at Fresenius Kabi’s Kalyani, India active pharmaceutical ingredient (API) plant, amongst a number of GMP violations cited in a July 2013 warning letter.
At the time, the firm responded by sacking QC personnel involved with the cover up and halted production at the plant - which makes some ingredients used in the firm's cancer drugs – but during a conference call Sunday to discuss Q2 2014 results, Fresenius Chairman Mark Schneider said manufacture had recommenced.
“Shipments to destinations outside of the US have commenced in Q2,” he said. “We expect shipments to the US later this quarter.”
He continued to tell investors the FDA is yet to have reinspected the site. However, “based on past inspection intervals we expected an FDA audit at the site at any time. Earlier this year the UK’s MHRA inspected the site successfully and confirmed GMP compliance.”
In 2012, the FDA issues a warning letter to Fresenius’ Grand Island, New York, injectables manufacturing plant – operated by subsidiary APP Pharmaceuticals – after insects were found in production areas and finished products.
Acknowledging the potential impacts for 2015 sales growth, Schneider said Fresenius has “proactively requested an inspection” of the site but was unsure when the FDA’s compliance team would be available. “They should see our inspection request as a sign of our quality commitment and confidence in the work that was accomplished on site.”
Some production had been shifted to APP’s other sites, including the Melrose Park, Chicago plant, but Schneider was asked whether the recent sale of its Raleigh, North Carolina facility had left the firm with limited capacity.
“That was always a non-strategic plan that gave us some additional lyophilisation capacity but it was not something that was meant to be build up as a major hub like Grand Island or Melrose Park.”