Answers
06/08/1994

<TITLE>FDA SUSPENDS LICENSE OF LUBBOCK, TEXAS, BLOOD FACILITY</TITLE>
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T94-30                                            Monica Revelle
June 8, 1994                                      (301) 443-4177

     FDA SUSPENDS LICENSE OF LUBBOCK, TEXAS, BLOOD FACILITY
                                
     FDA has been receiving inquiries about its actions to suspend
the establishment and product licenses of United Blood Services
Blood Systems Inc. (UBS-Lubbock) in Lubbock, Texas.  The agency has
also initiated proceedings to revoke these licenses. The following
can be used to answer questions. 
     FDA suspended UBS-Lubbock's license because of violations
involving blood collection and processing, documentation of donor
adverse reactions, donor suitability and record keeping.  The
suspension, which is effective immediately, prevents UBS-Lubbock
from shipping blood or blood components interstate.  The agency
moved to initiate proceedings to revoke the licenses of UBS-Lubbock
because FDA's investigation found evidence of falsification of
documents.  
     During an inspection conducted between March 16 and 25, 1994,
and a concurrent investigation, FDA documented numerous violations
including the failure to collect blood by aseptic methods.  FDA
investigators were told that employees sometimes broke the
sterility barrier by draining excess blood.
     FDA investigators were also told that, on numerous occasions,
mild to moderate donor adverse reactions were not documented.
                             -MORE-

                                        Page 2, T94-30, Lubbock  
     FDA also documented violations in the standard operating
procedures for determining donor suitability, one of the safeguards
of blood safety.  Donors were not always asked all of the screening
questions such as those related to AIDS or high-risk behavior.  
     Other violations included the failure to notify FDA regarding
errors or accidents in the manufacture of products, failure to
train employees adequately and failure to maintain accurate and
concurrent records.
     FDA contends that the nature of the deficiencies noted at UBS-
Lubbock represents a failure to comply with the regulations and
standards established to safeguard donors and the blood supply.  
     Under FDA's revocation procedures, UBS-Lubbock will be given
the opportunity to request a public hearing before an
administrative law judge on the proposed revocation of licenses. 
The Federal Food, Drug and Cosmetic Act and the Public Health
Service Act, which give FDA regulatory authority over blood
establishments engaged in interstate commerce, prohibit the
shipment of unlicensed or adulterated blood and blood products in
interstate commerce and provide penalties for an unlicensed firm
that engages in interstate commerce.    
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