Fresenius gets 2nd warning letter in 18 months
Fresenius Kabi, the generic drug unit for the German healthcare company, continues to stumble over quality issues in its manufacturing operations. The company has received its second FDA warning letter in 18 months, this time for a plant in India. And it has had two recent recalls because of glass particles found in vials of injectable drugs. Last year, inspectors reported finding insects in vials during an inspection of a plant in New York.
The latest warning letter has yet to be posted, but Fresenius said in a statement that the FDA found 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 Friday 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 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.
In February 2012, a plant in Grand Island, NY, operated by the Fresenius subsidiary APP Pharmaceuticals, was written up for a host of problems including an issue with insects found in the sterile manufacturing area. The company said that it believed the insects were introduced by the manufacturer of stoppers used in its vials at the time, but the FDA pointed out that it took 16 months for the company to audit the stoppermaker. The warning letter also raised questions about heparin manufacturing at that plant.
The drugmaker said it will take a one-time charge to cover the cost of fixing problems at its plant in India but did not indicate how much that might run. It said the write-off should not keep it from hitting its forecast earnings growth of 7% to 12% for the year.
- here's the company statement