FDA Warns Fresenius Must Improve Puerto Rican Plant

The FDA has told Fresenius, the manufacturer of GranuFlo, that its blood bag plant in Puerto Rico must improve manufacturing procedures, according to a report released by the company. Specifically, the company’s labeling and complaint-handling procedures have been criticized, although Fresenius was quick to reassure investors that the issues should not affect sales or earnings. Patients have not been put at risk, the company added.

The company’s labeling and complaint-handling procedures have been criticized.

This is the third such warning issued this year, with the FDA telling Fresenius in July that its plant in India required improved conditions. In March a related company was told that the sterilization process for certain dialyzers used to filter patients’ blood was not acceptable.

The latest FDA letter, revealed Friday, also cited the company’s filing for field alerts in non-compliance with FDA regulations, dating back to an inspection in April. Since then, the company has responded with a “detailed remediation action plan” and has made “significant progress”, the company said.

Granuflo, a drug used in hemodialysis for patients with acute of chronic kidney failure, was subject to a Class I recall in June 2012 following an increase in cardiac arrests and deaths in patients who received it as part of their treatment. The company has since faced lawsuits alleging that the concentrate, along with Naturalyte, can cause serious injury. The FDA has also investigated the possibility that the company violated federal policy by failing to alert patients to the dangers and risks associated with the procedure. The investigation began when the agency was leaked an internal memo indicating that they were aware of the impact inappropriate dosages of Granuflo could have on patients’ cardiac health. The memo warned dialysis centers of the problem, yet the company failed to provide a similar notice to the FDA.