Ashford Blood Bank, Inc.; Opportunity for Hearing on a Proposal to Revoke U.S. License No. 0740-001

Streszczenie

The Food and Drug Administration (FDA) is announcing an opportunity for a hearing on a proposal to revoke the establishment license (U.S. License No. 0740-001) and product licenses issued to Ashford Blood Bank, Inc., for the manufacture of Whole Blood and Red Blood Cells. The proposed revocation is based on the fact that authorized FDA employees have been unable to gain access to either of the establishment's locations for the purpose of carrying out a required inspection of the facility and that the manufacturing of products has been discontinued to an extent that a meaningful inspection or evaluation cannot be made.