[Federal Register Volume 60, Number 75 (Wednesday, April 19, 1995)]
[Notices]
[Pages 19595-19596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9578]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0299]
Plasmalab Donor Centers, Inc.; Revocation of U.S. License No.
1072-001
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. 1072-001) and
the product license issued to Plasmalab Donor Centers, Inc., doing
business as Douglas Plasmalab, for the manufacture [[Page 19596]] of
Source Plasma. This revocation notice affects only the Douglas
Plasmalab, Douglas, AZ, facility and has no bearing on other
establishment and product licenses issued to Plasmalab Donor Centers,
Inc. In a letter to FDA dated March 28, 1994, the firm requested that
the establishment and product licenses issued to its Douglas Plasmalab,
Douglas, AZ, facility be revoked and thereby waived its opportunity for
a hearing on the matter.
DATES: The revocation of the establishment license (U.S. License No.
1072-001) and product license became effective June 8, 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 has revoked the establishment license
(U.S. License No. 1072-001) and the product license for the manufacture
of Source Plasma issued to Plasmalab Donor Centers, Inc., doing
business as Douglas Plasmalab at 11 J Ave., Douglas, AZ 85607.
FDA inspected Douglas Plasmalab at 11 J Ave., Douglas, AZ, from
February 10, 1994, through March 9, 1994, following the report by the
establishment of an error from the reinfusion of the wrong red blood
cells to a donor undergoing plasmapheresis. The inspection revealed
serious deviations from Federal regulations. FDA has determined that
these deviations constitute a danger to health. These deficiencies
included, but were not limited to, the following: (1) Failure to follow
procedures designed to prevent the infusion of one donor's red blood
cells into another donor (21 CFR 640.65(b)(3)); (2) failure to follow
procedures designed to prevent contamination of red blood cells for
reinfusion (21 CFR 640.64(e)); (3) failure to limit the frequency of
Source Plasma donation to two times within a 7-day period (21 CFR
640.65(b)(5)); (4) failure to maintain accurate and concurrent records
to document the performance of each significant step in the collection,
processing, and storage of each unit of blood and blood components (21
CFR 606.160); and (5) failure to maintain adequate and complete
standard operating procedures that are available to personnel in the
areas where the procedures are performed for all steps in the
collection, processing, storage, and distribution of Source Plasma (21
CFR 606.100(b)). The inspection indicated serious noncompliance with
the donor protection standards which are intended to assure a
continuous and healthy donor population, as well as with standards
designed to assure the continued safety, purity, potency, and quality
of products manufactured.
In addition to the inspection, the agency conducted a concurrent
investigation that involved interviews with individuals knowledgeable
of the daily operations of Douglas Plasmalab. This investigation
revealed that deviations routinely occurred in important areas of the
plasmapheresis operation. These deviations included, but were not
limited to, the following: Maintenance of inaccurate red blood cell
reinfusion records, forced and unfiltered reinfusion of whole blood
into donors whose donation of blood exceeded the legally allowable
limit, and reinfusion of red blood cells which may have been
contaminated through a break in the closed sterile system of
collection.
FDA concluded that the serious nature of the deficiencies noted
during the inspection and concurrent investigation at Douglas Plasmalab
was a direct consequence of the establishment's disregard for the
applicable regulations and standards in the license applications and
constitutes a danger to public health warranting suspension pursuant to
21 CFR 601.6(a). In a letter to the firm dated March 17, 1994, FDA
suspended and confirmed telephone notice of the suspension of the
establishment license (U.S. License No. 1072-001) and the product
license for Source Plasma. In a letter to FDA dated March 28, 1994,
Plasmalab Donor Centers, Inc., voluntarily requested that its Douglas
Plasmalab licenses be revoked and thereby waived its opportunity for a
hearing. The agency granted the request by letter to the firm dated,
June 8, 1994, which revoked the establishment license (U.S. License No.
1072-001) 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 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. 1072-001) and the product
license for the manufacture of Source Plasma issued to Plasmalab Donor
Centers, Inc., Douglas, AZ, were revoked, effective June 8, 1994.
This notice is issued and published under 21 CFR 601.8 and the
redelegation at 21 CFR 5.67.
Dated: April 8, 1995.
Kathryn C. Zoon,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 95-9578 Filed 4-18-95; 8:45 am]
BILLING CODE 4160-01-F
