While the warning letter dating from February 2012 has not been closed out, new products made from the plant in Grand Island, New York can now receive approval after the US Food and Drug Administration (FDA) changed the status from ‘official action indicated’ to ‘voluntary action indicated’ (VAI).
“VAI status means the Grand Island facility is no longer operating under the restrictions applicable under the 2012 warning letter,” Fresenius spokesman Matthias Link told in-Pharmatechnologist.com, who added this is a positive step towards lifting the warning. “The FDA will first close out the previous inspections of Grand Island, and then will make a determination on the warning letter.”
The upgrade reflects remediation efforts made at the site acquired from APP Pharmaceuticals in 2008, and already this month a new product - Neostigmine Methylsulfate – has been approved by the FDA.
“We have other new products for Grand Island pending approval with the FDA and we expect that as many as five of these could now be approved this year.”
But an inspection by the FDA in July 2011 found a number of GMP violations which manifested into a warning letter. These included failures to fully investigate why insects were recurrently found in the manufacturing area, as well as being found in two vials of finished product.
Other problems the letter revealed included the failure to find the cause of out of specification results for batches of heparin API and heparin lock flush made at the site.
The FDA also issued a warning letter to a Fresenius Kabi API plant in Kalyani, India in July 2013, after an inspection found a number of issues including staff manipulating quality control data.
The firm responded by sacking staff involved with the cover up and halting production of a number of cancer drug ingredients made at the site. Production recommenced last August, though a closeout letter is yet to have been received.
CORRECTION - The original article stated the plant manufactures the fast-onset, short-acting sedative-hypnotic agent propofol, which has been considered by a number of states to be used in lethal injections. Propofol is not manufactured at the Grand Island site, rather it is made in locations in Europe.