[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
