FDA Shuts Down Florida Blood Bank for Multiple Violations

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, FDA Shuts Down Florida Blood Bank for Multiple Violations

So what’s going on at the U.S. Blood Bank in Doral, Florida? This is the first time in over ten years that the U.S. Food and Drug Administration has suspended a blood bank’s license. Authorities suspended the license of a Miami-area blood bank for multiple violations, including not properly notifying donors who may have been HIV-positive.
On July 9, U.S. Blood Bank based in Doral, Florida, received a later informing them that they failed to make “reasonable attempts” to notify about 120 donors between August 2013 and May 2015 who tested “reactive” for HIV and needed to get retested to verify the results.


U.S. Blood Bank defended themselves in a statement saying “not one of our units for transfusion was deemed to be anything but pure and safe.” Esther Hernandez, President of U.S. Blood Bank, says they did send letters to the affected donors, but didn’t want to scare the donors so they probably weren’t “aggressive” enough. The blood bank is in the process of fixing the violations and hopes to re-open soon.

The FDA says -but, that’s not all. They also failed to adequately inform at least six donors who tested reactive for Hepatitis B and C between September 2014 and February, but the public shouldn’t worry. According to company records and FDA officials, the potentially tainted blood was only shipped to research facilities.

U.S. Blood Bank was also cited for failing to obtain written approval to ship blood to hospitals and other facilities both inside Florida and outside the state. Several other violations included: failure to check donors for skin punctures or scars that might indicate drug use and improper documentation for blood moved from malfunctioning refrigerators.
The company was given 10 days to correct the violations and according to Hernandez they should have all their paperwork submitted to the FDA in plenty of time so they can re-open.

As of last week, the company was not collecting any blood and most of its 43 employees weren’t at work.

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