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

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URL: https://www.frixlaw.com/law-library/documents/fr%3A97-20496

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** August 5, 1997
- **Citation:** 62 FR 42133

## Text

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.

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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

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A97-20496. Public record. Not legal advice.