[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