The FDA has posted another round of manufacturing warnings. This time, the agency scolded a Daiichi Sankyo unit for "persistent" and "serious" problems at a plant in New York, while a Lonza manufacturing facility in Massachusetts was faulted for production problems. And because Lonza's plant is making APIs for other companies--namely Eisai and Ipsen--the warning letter could have a ripple effect.
First, the Daiichi unit's problems: The FDA letter to Luitpold Pharmaceuticals cites "significant" violations--and in a second round of inspections to boot. The facility had been inspected in February and March and then shut down in April for fixes, but the FDA wasn't satisfied with the results. In fact, Luitpold-made products--distributed by American Regent--have been recalled several times this year, some of them because drug vials contained visible particles.
The key problem is particulates found in injectable drugs. The agency said Luitpold's failures to fully investigate particulates and look into product failures were "repeat violations" that cropped up in annual inspections since 2008, Dow Jones reports. The Daiichi unit said it believes it has dealt with "most if not all" of the manufacturing shortfalls pointed out by the FDA.
Meanwhile, the problems at Lonza's plant in Hopkinton, MA, could affect Ipsen's growth failure treatment Increlex and Eisai's cancer drug Ontak. The FDA cited API potency testing shortfalls and quality-system problems. Although the manufacturing problems were mostly confined to production of the API for the Eisai drug, the FDA said production of other drugs, including Increlex, could be affected if Lonza doesn't correct its problems. Ipsen and Eisai both told in-Pharma Technologist they're working with Lonza and the FDA to make sure supplies of their drugs aren't affected.