[Federal Register Volume 63, Number 188 (Tuesday, September 29, 1998)]
[Notices]
[Page 51938]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25914]
[[Page 51938]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0751]
Biosera, Inc.; Revocation of U.S. License No. 1059
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. 1059) and the
product license issued to Biosera, Inc., for the manufacture of Source
Plasma. Biosera, Inc., has facilities in Denver, CO, and San Diego and
Orange, CA. In a letter to FDA dated April 2, 1998, the firm
voluntarily requested revocation of its establishment and product
licenses. In a letter dated May 12, 1998, FDA informed the firm that
the establishment and product licenses for all its locations were
revoked.
DATES: The revocation of the establishment license (U.S. License No.
1059) and the product license for all locations became effective May
12, 1998.
FOR FURTHER INFORMATION CONTACT: Astrid L. Szeto, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852-1448, 301-827-6210.
SUPPLEMENTARY INFORMATION: FDA has revoked the establishment license
(U.S. License No. 1059) and the product license for the manufacture of
Source Plasma issued to Biosera, Inc., at the following locations: (1)
717 Yosemite Circle, Denver, CO 80220 (U.S. License 1059-001); (2) 9040
Friars Rd., suite 430, San Diego, CA 92108 (U.S. License 1059-002); and
(3) 265 South Anita Dr., No. 10, Orange, CA 92668 (U.S. License 1059-
003).
FDA inspected facilities of Biosera, Inc., in Denver, CO, from June
23, 1997, through August 11, 1997; in San Diego, CA, from June 23,
1997, through July 11, 1997; and in Orange, CA, from June 23, 1997,
through September 3, 1997. These inspections revealed serious
deviations from applicable Federal regulations. The deficiencies noted
included, but were not limited to, the following: (1) Failure to
maintain accurate records concurrently with the performance of each
significant step in the collection, processing, storage, and
distribution of blood and blood components so that all steps can be
clearly traced (21 CFR 211.180, 600.12, 606.160, and 606.165); (2)
failure to adequately determine the suitability of donors (21 CFR 640.3
and 640.63); (3) failure to have the selection and scheduling of the
injection of the antigen performed by a qualified licensed physician
(21 CFR 640.66); (4) failure to maintain and follow adequate standard
operating procedures for all steps to be followed in the collection,
processing, storage, and distribution of blood and blood components (21
CFR 211.100 and 606.100); (5) failure to report important proposed
changes in manufacturing methods to the agency prior to implementation
(21 CFR 601.12); (6) failure to maintain adequate records of reports of
complaints of adverse reactions regarding each unit of blood or blood
product arising as a result of blood collection or transfusion (21 CFR
606.170); and (7) failure to observe, standardize, and calibrate
equipment used in the collection, processing, storage, and distribution
of blood and blood components (21 CFR 606.60). In addition to the
deficiencies noted previously, FDA obtained official samples of red
blood cells for immunization from inventory during the inspection of
the Orange, CA facility. Analysis by FDA revealed that vials of red
blood cells for immunization were falsely labeled with incorrect donor
information.
The deficiencies identified during the inspections represented a
comprehensive failure of the firm to maintain control over critical
aspects of its manufacturing process, as well as to exercise control
over the establishment in all matters relating to compliance, and to
assure that personnel were adequately trained and supervised and had a
thorough understanding of the procedures they performed, as required by
21 CFR 211.25 and 600.10(a) and (b). In addition, FDA determined that
the firm's red blood cells for immunization were misbranded within the
meaning of sections 502(a) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 352(a)) and section 351(b) of the Public Health Service Act
(the PHS Act) (42 U.S.C. 262(b)). The serious nature and extent of the
deficiencies observed at Biosera, Inc., led the agency to conclude that
they were the consequence of a careless disregard for the applicable
regulations and the standards in the firm's license. FDA determined
that these deficiencies constituted a danger to the public health that
warranted suspension under Sec. 601.6(a) (21 CFR 601.6(a)). By letter
dated October 17, 1997, to Biosera, Inc., FDA suspended the firm's
establishment license (U.S. License No. 1059) and product licenses for
Source Plasma effective October 20, 1997. The letter stated that FDA
intended to proceed under Sec. 601.6(b) to revoke the establishment
license and the product licenses.
In a letter to FDA dated October 22, 1997, Biosera, Inc., requested
that the matter of license revocation be held in abeyance. In a letter
to Biosera, Inc., dated March 13, 1998, FDA stated that the
inspectional history of the firm demonstrated a distinct pattern of
noncompliance with those requirements designed to ensure the safety,
purity, identity, and quality of plasma, as well as the standards for
donor protection that are intended to ensure a continuous and healthy
donor population. FDA determined, under 601.5(b) (21 CFR 601.5(b)),
that the firm had willfully acted with careless disregard of the
applicable regulations and standards, and denied the firm's request
that the revocation of license be held in abeyance. In the same letter,
FDA provided notice to the firm of FDA's intent to initiate proceedings
to revoke all establishment and product licenses encompassed under U.S.
License No. 1059 issued to Biosera, Inc., and to issue a notice of
opportunity for hearing under Sec. 601.5(b). In a letter to FDA dated
April 2, 1998, Biosera, Inc., requested voluntary revocation of U.S.
License No. 1059, and thereby waived its opportunity for a hearing.
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, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. These letters are available for public examination in the
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through
Friday.
Accordingly, under Sec. 601.5(a), section 351 of the PHS 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. 1059) and the product licenses for the
manufacture of the aforementioned product issued to Biosera, Inc., were
revoked, effective May 12, 1998.
This notice is issued and published under 21 CFR 601.8 and the
redelegation under 21 CFR 5.67(c).
Dated: September 16, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-25914 Filed 9-28-98; 8:45 am]
BILLING CODE 4160-01-F
