Baxter Recalls Rest of Heparin Products

The FDA investigation has included a Baxter plant in the United States, as well as a supplier of unrefined heparin to Baxter, Changzhou SPL in Changzhou City, China. The Chinese plant is largely owned by Scientific Protein Labs in Waunakee, Wisc., which is Baxter's main supplier of heparin.

"Our inspection team has finished the inspection of the Chinese facility," Michael Rogers, director of the FDA's Division of Field Investigations in the Office of Regulatory Affairs, said during the teleconference. "The inspection revealed that the facility is currently not manufacturing heparin at this time."

Rogers said the inspection team found "a number of potentially objectionable conditions related to the firm's manufacturing process."

"The inspection team's observations relate to deficiencies in the plant's evaluation of the steps it takes to remove impurities and its investigation of out-of-specification results. Issues related to waste material flow and deficiencies related to equipment," Rogers said.

Rogers noted that while the FDA was concerned about what it found in the Chinese plant, it was not prepared to make a connection between these observations and the adverse events associated with Baxter's heparin.

Inspection of the Chinese plant came after the FDA reported Feb. 19 that it had made a mistake and inspected the wrong Chinese plant, which had a similar name.

More information

For more on heparin, visit the U.S. National Library of Medicine.

SOURCES: Feb. 28, 2008, teleconference with Rear Admiral Sandra Kweder, M.D., deputy director, Office of New Drugs, Center for Drug Evaluation and Research; Michael Rogers, director, Division of Field Investigations, Office of Regulatory Affairs, U.S. Food and Drug Administration, Rockville, Md.