WASHINGTON—In a Sept. 15 letter, the U.S. Food and Drug Administration (FDA) warned Fresenius Medical Care that it had not properly investigated or fixed problems in two dialysis products and also expressed concern over the company’s phosphate drug Phoslo.
Between June 15 and Aug. 6, the FDA inspected Fresenius’ Waltham, Mass.-site where the company manufactures kidney dialysis products. The products named in the FDA’s warning letter were Liberty Cassettes and Naturalyte Acid Concentrate .
Click HERE to read the FDA warning letter, which was posted online Oct. 5.
In regards to the Liberty Cassettes, the FDA wrote, “Your firm failed to follow your health hazard assessment procedure in that you failed to identify any actions to reduce the risk of Liberty Cassettes in commercial distribution.”
Fresenius investigated 118 complaints between 2001 and 2009 regarding cassette leaks during dialysis treatments, according to the FDA letter. Fresenius identified the problem and put shipping holds on existing inventory and reworked the product in November 2009, but, according to the FDA, “failed to identify an action to address units in commercial distribution.”
Fresenius initiated on Aug. 26, a voluntary recall of the 98 lots of Liberty Cassettes, according to the letter.
In 2007, Fresenius received a complaint after a patient suffered "symptomatic hypocalcemia with parethesias and tetani" after having used the wrong concentration of Naturalyte Acid Concentrate product which was delivered to their residence.
“The complaint documented the difficulty discerning between different concentrates of calcium values for this product and using it in error,” the FDA wrote in the warning letter. “The complaint also noted that this was the second instance in which the incorrect concentration of a Naturalyte Acid Concentrate product had been delivered to the patient. No investigation into product labeling was initiated.”
The FDA said it was also concerned with Fresenius’ oversight of its contract drug manufacturers. Specifically, the FDA said it observed two issues with the phosphate binder Phoslo.
“We also observed the commercial release of Phoslo gelcaps that were found to contain grease,” the FDA wrote in the letter. “This decision was made after a previous Fresenius PAR report indicated that the three finished lots were to be used by the contractor for stability purposes and would not be released for commercial distribution. This failure in oversight of your release decisions is very concerning. FDA considers contamination of finished drug products with foreign material (e.g., grease) a significant product quality issue.”
Fresenius did initiate a recall of two lots of Phoslo gelcaps(#1308035 and #1308039)that had failing stability results, according to the FDA letter. In addition, Fresenius ended its relationship with the contract manufacturer of the drug, according to the letter.
“We are comfortable and proud of our 14-year record of FDA compliance,” said Jane A. Kramer, vice president, Public Affairs & Communication, Fresenius Medical Care North America. “We will respond to the FDA in the expected 15 working day time frame as required. We will work with the agency to resolve this issue and continue to regard our relationship with the FDA as critical to both our past and future success. We believe the warning letter will not have a material impact on the North American operations.”
