N.Y. Blood Center Agrees to Correct Deficiencies
Farley, Dixie, FDA Consumer
After FDA found continuing breaches of blood safety laws and regulations at the New York Blood Center, the facility and three of its officers agreed in a consent decree with FDA and the Department of Justice to a series of measures designed to ensure the integrity of its operations and thereby the safety of the blood it provides.
The government filed the decree last Dec. 16 simultaneously with a civil complaint in the U.S. District Court for the Southern District of New York.
This consent decree is the latest in a series of actions by FDA to ensure the continued safety of the U.S. blood supply. FDA entered into similar agreements with Blood Systems Inc./United Blood Systems in 1996, and with the American Red Cross in 1993.
The New York Blood Center collects blood at both fixed and mobile donation sites in New York City and Melville, N.Y., and in New Jersey. It also performs blood donor testing for facilities in New Jersey, Pennsylvania and Tennessee and imports and exports blood products to and from Europe.
In late 1994, FDA investigators inspected the center's New York City facility on Amsterdam Avenue and found that the center was:
* engaging in allegedly improper testing practices
* not maintaining complete and adequate standard operating procedures
* not following the company's existing standard operating procedures
* not following the manufacturer's testing instructions
* keeping incomplete, inaccurate records
* not adequately training employees
* maintaining inadequate security controls of computerized operations to ensure data integrity.
These findings led FDA to issue the blood center a warning letter in March 1995. A month later, the director of FDA's New York district office met with blood center senior officials, who then agreed to remedy deficiencies in their operations.
In late 199S, FDA investigators inspected the center's East 67th Street location, in New York City, examining a number of operations, including the center's interpretation of Western Blot testing. …