[Federal Register Volume 59, Number 131 (Monday, July 11, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-16617]
[[Page Unknown]]
[Federal Register: July 11, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 93N-0378]
North Carolina Memorial Hospital; Revocation of U.S. License No.
314
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. 314) and
product license issued to the North Carolina Memorial Hospital, doing
business as the Clinical Coagulation Laboratory, for the manufacture of
Source Plasma. In a letter to FDA dated February 10, 1993, the firm
voluntarily requested revocation of its establishment and product
licenses and thereby waived an opportunity for a hearing.
DATES: The revocation of the establishment license (U.S. License No.
314) and product license became effective August 24, 1993.
FOR FURTHER INFORMATION CONTACT: Stephen Ripley, 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 has revoked the establishment license
(U.S. License No. 314) and the product license issued to the North
Carolina Memorial Hospital, doing business as the Clinical Coagulation
Laboratory, University of North Carolina School of Medicine, Chapel
Hill, NC 27514, for the manufacture of Source Plasma.
FDA conducted an inspection of the Clinical Coagulation Laboratory
between July 30 and August 15, 1991. The inspection documented serious
deviations from the applicable Federal regulations and the biologics
standards in the firm's license. Deviations identified during the
inspection included, but were not limited to, the following: (1)
Failure to adequately determine donor suitability, in that: (a) three
donors who admitted to a history of hepatitis, liver disease, or
jaundice were regularly accepted for Source Plasma donation (21 CFR
640.63(c)(11)); (b) two donors who previously tested repeatedly
reactive for the hepatitis B surface antigen (HBsAg) continued to be
accepted for donation, despite having never met the established
criteria for donor reentry as described in the December 2, 1987, FDA
HBsAg protocol (21 CFR 610.41); (c) two donors who failed to donate for
a period of 6 months were not processed as new donors (21 CFR
640.65(b)(1)(iii)); and (d) five donors did not have serum protein
electrophoresis testing performed every 4 months (21 CFR
640.65(b)(1)(i)); (2) failure to limit the frequency of Source Plasma
donation to two times within a 7-day period, in that at least two
donors were allowed to donate three times in a 7-day period (21 CFR
640.65(b)(5)); (3) failure to observe, standardize, and calibrate
equipment used in the collection, processing, and distribution of blood
components (21 CFR 606.60); (4) failure to maintain adequate and
complete standard operating procedures for all steps in the collection,
processing, storage, and distribution of blood components (21 CFR
606.100(b)); and (5) failure to report important changes in responsible
personnel or manufacturing methods to FDA's Center for Biologics
Evaluation and Research (21 CFR 601.12 (a) and (b)).
FDA determined that the deviations from Federal regulations were
significant and constituted a danger to public health, warranting a
suspension pursuant to 21 CFR 601.6(a). In a letter to the North
Carolina Memorial Hospital dated September 3, 1991, FDA detailed the
violations noted above and suspended the firm's establishment and
product licenses for the manufacture of Source Plasma. In a letter to
the firm dated May 20, 1992, FDA indicated that the firm had responded
satisfactorily to FDA's September 3, 1991, suspension letter. In the
same letter, FDA permitted the firm to resume collecting and storing
Source Plasma on a limited basis for the purpose of reinspection to
determine compliance.
FDA conducted a followup inspection of the firm between July 27 and
July 29, 1992. The inspection documented several continuing deviations
from Federal regulations. These deviations included, but were not
limited to, the following: (1) Inadequate facilities to provide for the
storage of blood or blood components; (2) incomplete or incorrect
disposition records; and (3) incomplete or inadequate written
procedures. FDA permitted the firm to continue to collect and store
Source Plasma on a limited basis, but FDA did not permit the firm to
distribute the prepared plasma until otherwise notified by FDA.
FDA attempted to conduct a reinspection of the firm on February 2,
1993, to, in part, determine the firm's status. During this inspection,
it was observed that the donor chair had been removed and that no
plasma had been collected since the inspection ending July 29, 1992.
The inspection was terminated because a meaningful inspection could not
be performed.
In a letter to FDA dated February 10, 1993, the firm requested
voluntary revocation of its licenses and thereby waived its opportunity
for a hearing under 21 CFR 601.5(a). The agency granted the licensee's
request by letter dated August 24, 1993, which revoked the
establishment license (U.S. License No. 314) and the product license
for the manufacture of Source Plasma.
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 include the following: FDA letters of
September 3, 1991, May 20, 1992, and August 24, 1993; and the firm's
letter of February 10, 1993. These documents are available in the
Dockets Management Branch (address above) between 9 a.m. and 4 p.m.
Monday through Friday.
Accordingly, under section 351 of the Public Health Service Act (42
U.S.C. 262), 21 CFR 601.5, 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. 314) and the product
license issued to the North Carolina Memorial Hospital, doing business
as the Clinical Coagulation Laboratory, for the manufacture of Source
Plasma were revoked, effective August 24, 1993.
This notice is issued and published under 21 CFR 601.8 and the
redelegation at 21 CFR 5.67.
Dated: June 27, 1994.
Michael G. Beatrice,
Deputy Director, Center for Biologics Evaluation and Research.
[FR Doc. 94-16617 Filed 7-8-94; 8:45 am]
BILLING CODE 4160-01-F
