1. Generics Bulletin

Fresenius Kabi: No Launches From US Melrose Park Facility In 2021

Market Fears Warning Letter At Key US Facility

 
• By Dean Rudge

Fresenius Kabi saw a sales and earnings slump in its North America business in the final quarter of last year, which dragged heavily on the firm’s full-year operations. Management have conceded that one of those factors, manufacturing issues at its Melrose Park facility, will blow into 2021, with no product approvals or launches anticipated from the site.

FDA entrance sign 2016
'Getting final clarity on this situation will require a physical inspection,' Kabi believes • Source: Shutterstock

Fresenius Kabi is keen for a physical US Food and Drug Administration reinspection at its large-scale sterile injectables plant in Melrose Park near Chicago “sooner rather than later,” after conceding that no product launches from the site are anticipated in 2021.

Last year, an FDA inspection at Melrose Park revealed multiple Form 483 deficiencies, including a failure to properly deal with product contamination

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Manufacturing

More from Business