[Federal Register Volume 60, Number 208 (Friday, October 27, 1995)]
[Notices]
[Pages 55036-55037]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26631]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 93N-0046]
Westmar Oceanside, Inc.; Revocation of U.S. License No. 828
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. 828) and the
product license issued to Westmar Oceanside, Inc., for the manufacture
of Source Plasma. A notice of opportunity for a hearing on a proposal
to revoke the licenses was published in the Federal Register of May 6,
1993. In a letter to FDA dated June 1, 1993, a representative of
Westmar Oceanside, Inc., indicated that the firm was no longer in
business and requested voluntary revocation of the establishment
license and product license and thereby waived an opportunity for a
hearing.
DATES: The revocation of the establishment license (U.S. License No.
1082) and product license became effective August 3, 1993.
FOR FURTHER INFORMATION CONTACT: Stephen M. Ripley, Center for
Biologics Evaluation and Research (HFM-635), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-
3074.
SUPPLEMENTARY INFORMATION: FDA has revoked the establishment license
(U.S. License No. 828) and the product license issued to Westmar
Oceanside, Inc., 1024 South Hill St., Oceanside, CA 92504, for the
manufacture of Source Plasma.
By letter dated December 11, 1991, FDA advised Westmar Oceanside,
Inc., that FDA intended to initiate proceedings to revoke the
establishment and product licenses. In the Federal Register of May 6,
1993 (58 FR 26982), FDA published a notice of opportunity for a hearing
on the proposed revocation of the licenses pursuant to 21 CFR 12.21(b),
as provided in 21 CFR 601.5(b). As described in the notice of
opportunity for a hearing, the grounds for the proposed license
revocation included the following: (1) The results of the FDA
inspection of Westmar Oceanside, Inc., conducted in August through
September 1991; (2) the results of an FDA investigation of Westmar
Oceanside, Inc., conducted concurrently with the August/September 1991
inspection; (3) a determination by FDA that the deviations documented
during the August/September 1991 inspection and investigation showed
serious noncompliance with the applicable biologics regulations and
standards of the firm's license; and (4) a determination by FDA that
the violations at the firm were significant and willful. 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, rm. 1-23, 12420 Parklawn Dr., Rockville, MD
20857.
The notice of opportunity for a hearing provided 30 days for
Westmar Oceanside, Inc., to submit a written request for a hearing, as
specified in 21 CFR 12.21(b), and 60 days to submit any data or
information justifying a hearing. The notice of opportunity for a
hearing provided 60 days for other interested persons to submit written
comments on the proposed revocation action. A representative for
Westmar Oceanside, Inc., responded to the notice of opportunity for a
hearing by letter dated June 1, 1993. The letter stated that the firm
was no longer in business and requested voluntary revocation of the
firm's establishment license and product license and thereby waived an
opportunity for a hearing. In a letter dated August 3, 1993, to the
firm, FDA revoked the establishment license (U.S. License No. 828) and
the product license issued to Westmar Oceanside, Inc.
No other written comments on the proposed revocation were received
within the prescribed 60 days specified in the notice of opportunity
for a hearing.
FDA has placed a copy of FDA's August 3, 1993, letter on file with
the Dockets Management Branch (address above) under the docket number
found in brackets in the heading of this notice. This document is
available for public examination in the Dockets Management Branch
between 9 a.m. and 4 p.m., Monday through Friday.
Accordingly, under 21 CFR 601.5, 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 5.68),
the establishment license (U.S. License No. 828) and the product
license issued to Westmar Oceanside, Inc., for the manufacture of
Source Plasma were revoked, effective August 3, 1993.
This notice issued and published under 21 CFR 601.8 and the
redelegation at 21 CFR 5.67.
[[Page 55037]]
Dated: October 17, 1995.
Kathryn C. Zoon,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 95-26631 Filed 10-26-95; 8:45 am]
BILLING CODE 4160-01-F