The American Red Cross has been walloped with a $16 million fine for regulatory missteps concerning blood products. The fine comprises $6.39 million for GMP violations and $9.79 million for the mismanagement of such blood products as red cells, plasma and platelets.
FDA inspections in 2008 and 2009 found shortcomings in identifying and investigating manufacturing problems. Since then, the US drug supply caretaker has instituted standardized procedures.
But the FDA says that more needs to be done. To date, the regulator has communicated in writing a dozen times about manufacturing and management matters. And it has fined the Red Cross more than $21 million.
The FDA says in a statement that it hopes the fines "will encourage the Red Cross to act more quickly to take the actions necessary" to correct the violations.
- see the FDA release