[Federal Register Volume 60, Number 75 (Wednesday, April 19, 1995)]
[Notices]
[Pages 19596-19597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9577]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0298]


Putnam County Blood Bank, Inc.; Revocation of U.S. License No. 
1121

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocation of the establishment license (U.S. License No. 1121) and the 
product licenses issued to Putnam County Blood Bank, Inc., (PCBB) for 
the manufacture of Whole Blood, Red Blood Cells, Platelets, and Plasma. 
In a letter to FDA dated April 29, 1994, the firm requested that its 
establishment and product licenses be revoked and thereby waived its 
opportunity for a hearing on the matter.

DATES: The revocation of the establishment license (U.S. License No. 
1121) and product licenses became effective June 3, 1994.

FOR FURTHER INFORMATION CONTACT: Timothy W. Beth, Center for Biologics 
Evaluation and Research (HFM-635), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-594-3074.

SUPPLEMENTARY INFORMATION: FDA conducted an inspection of PCBB, 2919 
Kennedy St., Palatka, FL 32077, from September 1, 1992, through October 
6, 1992. The inspection revealed serious deviations from Federal 
regulations. FDA determined these deviations to constitute a danger to 
public health. These deficiencies included, but were not limited to, 
the following: (1) Failure to establish scientifically sound and 
appropriate specifications, standards, and test procedures to assure 
that blood and blood components are safe, pure, potent, and effective 
(21 CFR 606.140(a) and 610.45(c)), and (2) failure to institute systems 
capable of precluding release of unsuitable blood and blood components 
(21 CFR 640.3(b) and (c) and 606.160(b)(1)(ii) and 
(e)). [[Page 19597]] 
    Because of these serious deviations, FDA concluded that the 
management at PCBB did not adequately demonstrate the ability to 
operate the establishment in a manner that assured compliance with 
Federal regulations or accepted standard operating procedures, or to 
ensure that personnel were adequately trained and supervised and had a 
thorough understanding of the procedures that they performed as 
required by 21 CFR 600.10(a) and (b) and 606.20(a) and (b). These 
conditions at PCBB were considered to constitute a danger to public 
health warranting license suspension pursuant to 21 CFR 601.5(b) and 
601.6(a). FDA accordingly suspended the firm's licenses by letter dated 
November 6, 1992.
    In addition to the suspension of establishment and product 
licenses, and in order to preclude the distribution of violative units, 
and to address those questionable units already in distribution 
channels, FDA requested that PCBB immediately and concurrently perform 
the following: (1) Review test records for antibody to the human 
immunodeficiency virus (Type I), and then identify and defer all donors 
who may have been misinterpreted as suitable due to improper donor 
reentry procedures; (2) develop and implement a plan to identify and 
defer all donors who, during the medical history interview, have 
provided information which may deem such donors as ineligible, and (3) 
identify and recall all units collected from such donors, and notify 
all consignees of transfusible and nontransfusible blood and blood 
components of the test/medical history of the units. In a letter to the 
firm dated March 9, 1994, FDA concluded that the recall was complete.
     In a letter to FDA dated April 29, 1994, PCBB voluntarily 
requested that its licenses be revoked and thereby waived its 
opportunity for a hearing. The agency granted the request in a letter 
dated June 3, 1994, which revoked the establishment and product 
licenses.
    FDA has placed copies of the letters relevant to the license 
revocation on file under the docket number found in brackets in the 
heading of this document with the Dockets Management Branch (HFA-305), 
Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, 
MD 20857. These documents are available for public examination in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.
    Accordingly, under 21 CFR 601.5, section 351 of the Public Health 
Service Act (42 U.S.C. 262), and under authority delegated to the 
Commissioner of Food and Drugs (21 CFR 5.10) and redelegated to the 
Director, Center for Biologics Evaluation and Research (21 CFR 5.68), 
the establishment license (U.S. License No. 1121) and the product 
licenses for the manufacture of Whole Blood, Red Blood Cells, 
Platelets, and Plasma issued to Putnam County Blood Bank, Inc., 
Palatka, FL, were revoked, effective June 3, 1994.
    This notice is issued and published under 21 CFR 601.8 and the 
redelegation at 21 CFR 5.67.

    Dated: April 11, 1995.
Kathryn C. Zoon,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 95-9577 Filed 4-18-95; 8:45 am]
BILLING CODE 4160-01-F