FDA Warns Baxter It May Lose License for Screening Blood

Baxter International Inc., which runs one of the largest laboratories for screening blood for AIDS, hepatitis and other illnesses, has been warned it may lose its license unless it takes corrective action, government documents revealed Wednesday.

Documents from the Food and Drug Administration show that Baxter Screening Laboratory of Round Lake, Ill., was found in violation of FDA quality control standards in 69 instances during inspections made by the agency last fall.

The facility tests more than 2 million blood samples a year for a variety of diseases including AIDS, hepatitis and syphilis, from 10 regional blood banks. Donated blood from the banks goes to hospitals for use in surgery.

The information was included in a letter dated Feb. 2 from the FDA and obtained by Reuters under the Freedom of Information Act.

“The company considers the FDA’s findings very serious and is working closely with the agency to correct them,” said Baxter spokesman Les Jacobson. Deerfield, Ill.-based Baxter is a major manufacturer of health-care supplies, including hospital gowns, gloves, heart valves, monitoring equipment, and diagnostic instruments. Its sales last year were $7.4 billion.

The company said the most serious issue raised by the FDA involved six plasma units that were classified as negative for hepatitis-B even though the test initially was positive.

“Clerical errors were responsible for the misclassification,” the company said. “After further testing the six units tested negative.”

Baxter said it is spending more than $1 million for additional staff and is expanding and improving the facility, the company’s only blood screening laboratory. New training and operating procedures to assure accuracy and safety have begun and the company said it is using new computer systems to automate data collection and record-keeping.

In the letter, the FDA said some of Baxter’s testing procedures do not comply with the agency’s standards and requirements. In addition, the FDA said many of the deficiencies found during an earlier inspection in August, 1988, have not been corrected.