Following an April inspection the FDA raised concerns about product labeling and complaint-handling processes at the blood bag manufacturing plant, but said the problems did not lead to any cases of patient harm.
The warning letter also raises concerns over the company’s field alert filing process, which the FDA said was not up to standards. Despite notching its 3rd offense this year, Fresenius affirmed 2013 guidance estimates.
The warning letter over the Puerto Rico blood bag plant follows last month’s FDA warning about the company’s Kalyani, India-based plant, which manufactures cancer drugs.
In March, the German dialysis device maker landed in hot water over inadequate design verification and validation procedures at a plant in Ogden, Utah.
The news didn’t move FMS shares much yesterday. Shares closes at $33.54, up 0.3% on the day.