[Federal Register Volume 62, Number 150 (Tuesday, August 5, 1997)]
[Notices]
[Pages 42133-42134]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20496]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 95N-0155]


Bio-Components, Inc.; Revocation of U.S. License No. 1160

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocation of U.S. License No. 1160, which includes the establishment 
license and the product licenses for the manufacture of Source Plasma 
and Source Leukocytes, issued to Bio-Components, Inc. (BCI). BCI did 
not respond to a notice of opportunity for a hearing on a proposal to 
revoke its licenses.

DATES: The revocation of U.S. License No. 1160 is effective August 5, 
1997.
FOR FURTHER INFORMATION CONTACT: Annette A. Ragosta, Center for 
Biologics Evaluation and Research (HFM-630), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-
3074.

SUPPLEMENTARY INFORMATION: FDA is revoking the establishment license 
(U.S. License No. 1160) and the product licenses issued to Bio-
Components, Inc., 440 North Beach St., Daytona Beach, FL 32114, for the 
manufacture of Source Plasma and Source Leukocytes. The revocation is 
based on the failure of BCI, and its responsible management to conform 
to the applicable standards established in the license and to the 
applicable Federal regulations designed to ensure the continued safety, 
purity, and potency of the manufactured product (see Sec. 601.5(b)(4) 
(21 CFR 601.5(b)(4))).
    In a letter dated May 13, 1994, FDA informed BCI of the agency's 
intent to revoke the firm's license and its intent to issue an 
opportunity for a hearing on the proposed revocation. In the Federal 
Register of January 30, 1996 (61 FR 3040), FDA published a notice of 
opportunity for a hearing on the proposed revocation of the license 
under Sec. 12.21(b) (21 CFR 12.21(b)), as provided in Sec. 601.5(b). As 
described in the notice of opportunity for a hearing, the grounds for 
the proposed license revocation were based on the results of an FDA 
inspection of BCI conducted between January 21, 1993, and February 12, 
1993. FDA determined that the deviations documented during the January 
and February 1993 inspection constituted a danger to the public health 
and accordingly suspended BCI's license in a letter dated March 19, 
1993. FDA subsequently determined that BCI demonstrated careless 
disregard for the applicable regulations and the applicable standards 
in its license due to, among other things, the firm's past history of 
noncompliance and the firm's failure to submit an adequate corrective 
action plan. Due to this evidence of willfulness, FDA did not provide 
BCI with further opportunity to demonstrate or achieve compliance. 
Documentation in support of the proposed revocation had been placed on 
file for public examination with the Dockets Management Branch (HFA-
305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.
    The notice of opportunity for a hearing provided BCI with 30 days 
to submit a written request for a hearing, as specified in 
Sec. 12.21(b), and 60 days to submit any data or information justifying 
a hearing. The notice provided other interested persons with 60 days to 
submit written comments on

[[Page 42134]]

the proposed revocation action. BCI did not submit, within the 30-day 
time period, a written request for a hearing on the proposed revocation 
of its license. The 30-day time period, prescribed in the notice of 
opportunity for a hearing and in the regulations, may not be extended. 
No other written comments on the proposed revocation were received 
within the prescribed 60 days specified in the notice of opportunity 
for a hearing.
    Accordingly, under 21 CFR 12.38, 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 5.67), 
U.S. License No. 1160, issued to Bio-Components, Inc., is revoked 
effective August 5, 1997.
    This notice is issued and published under 21 CFR 601.8.<SUP> </SUP>

    Dated: July 28, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-20496 Filed 8-4-97; 8:45 am]
BILLING CODE 4160-01-F