...

Inspections of intrastate blood collection establishments in 1974 indicated several widespread problems: slightly less than half the inspections revealed failure to adequately establish donor suitability, about the same percentage demonstrated problems with their blood collection techniques, and half exhibited faulty hepatitis testing. To get a better handle on the massive effort to regulate the blood and blood product industries, the Bureau of Biologics initiated a database, the Blood Establishment Inspection and Registration System—finalized in 1976—to monitor the thousands of annually renewed registrations and licenses, the biennial inspections of several thousand facilities, the compliance history and progress with the firms, and impact of regulatory changes.

A 1979 action against another problematical blood bank had to negotiate the need to compel compliance against the realities of providing a vital service. A blood bank that was the largest supplier to South Florida, distributing annually 140,000 units to 54 hospitals—90 percent of the need in that area, was doing so without much regard for the required good manufacturing practices, as documented in recent FDA inspections. Thus, enjoining the firm from further operations until they could come in compliance would deprive a large population of crucial biologicals. Thus, the agency and the blood bank reached a consent decree of permanent injunction, in which the blood bank agreed to bring its operations into compliance immediately, as well as bringing in an outside expert toward making all necessary changes for GMP compliance long-term. At the same time, the government prevented an interruption of a crucial supply of biologicals with an expectation that corrections would be made quickly.

...

Prompted by concerns with the transmission of the AIDS virus, FDA launched an intensive inspection program of all blood banks and plasma centers in 1988. Over eleven percent of the facilities were found to have significant enough violations to prompt a regulatory response. These problems included the processing of blood suspected of contamination with the AIDS virus, although there were no cases where blood or products confirmed to be so contaminated were released. During this program inspections of American Red Cross (ARC) blood banks in Nashville and Washington, D. C. indicated operational errors leading to the release of unsuitable units of blood and blood products, errors that continued despite corrections. So, in 1988 FDA and ARC signed a voluntary agreement in which the latter would improve operations across the nation by establishing closer oversight of regional operations by national headquarters, standardizing operating procedures, and monitoring more closely computerized information to prevent release of unsuitable blood.

The Center for Biologics Evaluation and Research (CBER), which is what the Bureau of Biologics was eventually called, served notice in 1990 to a major testing laboratory where agency inspections revealed serious deficiencies in blood testing practices for both hepatitis and HIV that their license would be revoked absent the necessary corrections to come into compliance with the required standards and regulations, and a plan to accomplish that had to be filed with FDA within 30 days.  Until that time the agency would not process any license applications from the laboratory’s corporation that provided for any FDA-mandated test to be done at that laboratory.  In addition, FDA notified blood and plasma centers using that laboratory that their licenses, too, would be affected if the laboratory could not or would not come into compliance.  The laboratory indeed submitted a roadmap toward compliance within the time frame required.

...