German drugmaker Fresenius Kabi has landed in hot water with the FDA yet again over problems at one of its manufacturing plants. Just weeks after the FDA savaged a cancer drug plant in India for lying to investigators and hiding test results, it has received yet another warning letter, this time for problems at a Puerto Rico blood bag manufacturing facility.
The most recent missive came Aug. 16 and is for a plant in Maricao, Puerto Rico, that it picked up in December when it closed on its acquisition of Fenwal for a reported $1.1 billion. The company said in a release that observations are primarily related to complaint-handling procedures, labeling issues and filing of field alerts. It said none of the observations were tied to any adverse events and that production at the facility is ongoing. The drugmaker said it takes the problems seriously and has made significant progress in remedying them.
Last month Fresenius Kabi was equally low-key when the generic drug unit for the German healthcare company Fresenius acknowledged it had received a warning letter for its Kalyani, India, oncolytic API plant. The announcement came ahead of the FDA publicly posting the July 1 letter, and the Fresenius description did not come close to indicating the depth of the problems the FDA found there.
The FDA inspectors said employees at the facility lied about blending APIs that failed quality tests into batches that passed in an effort to hit specifications; however, the Fresenius release didn't mention that. Nor did it mention that FDA inspectors saw an employee 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 personal computers were removed from the plant to "conceal data manipulations," a practice the FDA called "very worrisome." The company later said it had fired the managers at the plant and would not tolerate that kind of conduct.
A plant in Grand Island, NY, operated by the drugmaker's APP Pharmaceuticals subsidiary was written up in February 2012 for problems that included an issue with insects found in the sterile manufacturing area.
- here's the release