Beauregard Plasma, Inc., Jackson Plasma, Inc., Baton Rouge Plasma, Inc., and Claiborne Plasma, Inc.; Opportunity for Hearing on a Proposal to Revoke U.S. License Nos. 1030, 1031, 1032, and 1033

Короткий зміст

The Food and Drug Administration (FDA) is announcing an opportunity for a hearing on a proposal to revoke the biologics licenses (U.S. License Nos. 1030, 1031, 1032, and 1033) issued to Beauregard Plasma, Inc.; Jackson Plasma, Inc.; Baton Rouge Plasma, Inc.; and Claiborne Plasma, Inc., respectively, for the manufacture of Source Plasma. The proposed revocations are based on the fact that authorized FDA employees have been unable to gain access to these establishments' locations for the purpose of carrying out required inspections of the facilities, which are no longer in operation, and manufacturing of products has been discontinued to an extent that meaningful inspections cannot be made.