Fresenius Kabi, the generic drug unit for the German healthcare company, earlier this month acknowledged the warning letter the FDA had sent its oncolytic API plant in Kalyani, India. Its announcement said the FDA had found problems in manufacturing quality, but its description did not come close to indicating the depth of the problems the FDA found there.
In fact, the warning letter said employees at the plant lied about having blended APIs that failed quality tests into batches that passed in an effort to hit specifications. It didn't mention that an employee was seen trying to hide test results about that practice in his pocket or that employees confessed to manipulating data and then hiding it.
The warning letter also said the company confessed that during the January inspection and previous inspections, high-pressure liquid chromatography equipment and personnel computers were removed from the plant to "conceal data manipulations," a practice the FDA called "very worrisome."
Using language from a recent draft guidance on delaying tactics that can lead to an import alert or even criminal action, the warning letter said Fresenius "repeatedly delayed, denied, limited or refused to provide information to the FDA investigators." Similar language was included in a warning letter issued this month to Wockhardt for one of its Indian plants. That facility was found to be destroying records related to the practice of retesting samples and eliminating failed results.
The FDA recommended that Fresenius get expert consultants to make improvements and warned that it could deny future applications for products from the plant if problems are not quickly addressed. The company has already said it takes the findings very seriously and has submitted a plan of action to the FDA.
The warning letter is the second Fresenius has received in 18 months. A plant in Grand Island, NY, operated by its APP Pharmaceuticals subsidiary, was written up in February 2012 for problems that included an issue with insects found in the sterile manufacturing area. The drugmaker has 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 warning letter