Fresenius Kabi, the generic drug unit for the German healthcare company, this week received an FDA warning letter for a plant in India. The company said it is dealing with the issues, but its work on the plant will not affect its previous guidance. The company is still expecting its net income to grow 7% to 12% for the year.
The drugmaker said the FDA found some manufacturing problems during a January inspection of its oncolytic API plant in Kalyani, India. The company claims to have "self-identified" some of the problems and has already made significant progress in fixing them. It did close down the plant in January to get on top of the issues but said today that after submitting a plan of action to the FDA it has restarted production. "The company takes this matter very seriously and intends to comprehensively respond in a timely manner to the Warning Letter," it said.
The drugmaker said it will take some one-time charges to cover the cost of the plant improvements but did not indicate how much those might run. It said that should not keep it from hitting its forecast earnings.
The news came just a week after Fresenius Kabi recalled four lots of the injectable drug benztropine mesylate because of potential contamination with glass particles. Fresenius Kabi conducted a separate recall in late May of magnesium sulfate injection, also for the risk of glass particles in vials.
The FDA is doing more inspections of facilities outside the U.S. and has taken a number of actions recently against facilities in India. India, along with China, manufactures the vast majority of the active pharmaceutical ingredients used in drugs worldwide. In May, India's Wockhardt said that the FDA had issued an import alert that could cost it $100 million in lost sales because of manufacturing problems at a plant in Aurangabad in Maharashtra.
- here's the release