FDA Shuts Down South FL Blood Bank For Violations
Federal authorities have suspended the license of a Miami-area blood bank for violations that include improperly notifying donors who may have been HIV-positive.
It’s the first time the U.S. Food and Drug Administration has suspended a blood bank’s license in more than a decade.
According to a July 9 letter from the FDA, Doral, Florida-based U.S. Blood Bank did not make “reasonable attempts” to notify at least 120 donors between August 2013 and May who tested reactive for HIV and would need another test to verify the results.
In a statement to The Miami Herald, U.S. Blood Bank said “not one of our units for transfusion was deemed to be anything but pure and safe.”
President Esther Hernandez said letters sent to the affected donors about the test results “weren’t aggressive.”
“It was maybe our fault, but we didn’t want the donors to be scared,” she said.
The company is working to address the violations and hopes to re-open, Hernandez said.
U.S. Blood Bank also failed to adequately inform at least six donors who tested reactive for Hepatitis B and C between September 2014 and February, according to the FDA.
There’s little risk to the public because the potentially tainted blood was only shipped to research facilities, according to the company and FDA officials.
“Due to the nature of the violations, FDA believes that there is little risk to blood and blood product recipients, and has found no evidence to suggest that these violations resulted in serious health consequences in recipients,” FDA spokeswoman Sarah Peddicord said.
Federal officials also cited U.S. Blood Bank for failing to obtain written approval to ship blood to hospitals and other facilities both inside Florida and outside the state.
Other violations included failures to check donors for skin punctures or scars that might indicate drug use and improper documentation for blood moved from malfunctioning refrigerators.
The company had 10 days to respond to the violations listed in the letter.
“We’re working very hard right now and by the end of next week we should have all of our paperwork submitted to the FDA,” said Hernandez. “We’re hoping to re-open.”