[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