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

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.

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