Universal Reagents, Inc.; Revocation of U.S. License No. 0887

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the revocation of the biologics license (U.S. License No. 0887) issued to Universal Reagents, Inc., (URI) for the manufacture of Source Plasma. A notice of opportunity for a hearing on a proposal to revoke the license was published in the Federal Register of July 10, 2003. URI requested a hearing by letter dated August 11, 2003. Subsequently, the authorized official of URI voluntarily requested revocation of its biologics license (U.S. License No. 0887) by letter dated December 29, 2003. In light of URI's request for revocation of its license, the firm's request for an opportunity for a hearing on the issue of license revocation became unnecessary. FDA, therefore, proceeded to revoke the license.

DATES:

The revocation of U.S. License No. 0887 became effective March 2, 2004.

FOR FURTHER INFORMATION CONTACT:

Nathaniel L. Geary, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, suite 200N, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

FDA has revoked the biologics license (U.S. License No. 0887) for the manufacture of Source Plasma issued to URI, 2858 North Pennsylvania St., Indianapolis, IN 46205.

By certified return receipt letter, dated October 23, 2002, issued under § 601.5(b) (21 CFR 601.5(b)), FDA notified the firm of FDA's intent to revoke U.S. License No. 0887 and announced its intent to offer an opportunity for a hearing. Because URI did not submit a response to FDA's letter dated October 23, 2002, and did not waive an opportunity for hearing under 21 CFR 12.21(b), FDA issued a notice of opportunity for a hearing in the Federal Register of July 10, 2003 (68 FR 41162), on the proposal to revoke the biologics license (U.S. License No. 0887) issued to URI for the manufacture of Source Plasma. As described in the notice of opportunity for a hearing, the grounds for the proposed license revocation included the following: (1) The results of an FDA inspection of the firm conducted between May 29 and June 3, 2002; as well as from the inspection on June 7, 2002, of Central Indiana Regional Blood Center, Inc. (CIRBC), Indianapolis, IN, which performed infectious disease testing for URI under a contract agreement; (2) FDA's determination through its investigation and inspections of both URI and CIRBC, that URI had significant deviations from the standards established in its license as well as in the applicable Federal regulations; and (3) documentation that URI had willfully engaged in violative recordkeeping practices and falsified records it submitted to FDA. In support of the proposed revocation, FDA had placed documentation on file for public examination with the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Following publication of the notice of opportunity for a hearing on July 10, 2003, FDA's Division of Dockets Management received a letter (via electronic transmission), dated August 11, 2003. In the letter, URI requested a hearing on the proposed license revocation and set forth information to support its request.

While the request for hearing was pending, the authorized official of the firm voluntarily requested revocation of U.S. License No. 0887 by letter dated December 29, 2003. FDA notified URI by letter of March 2, 2004, that the license had been revoked. Based on the voluntary request for revocation of U.S. License No. 0887, URI's request for a hearing on the issue of license revocation became unnecessary.

Accordingly, under § 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 (FDA Staff Manual Guides (SMG) 1410.10)) http://www.fda.gov/smg/default.htm and redelegated to the Director, Center for Biologics Evaluation and Research (SMG 1410.204), the biologics license (U.S. License No. 0887) for the manufacture of Source Plasma issued to URI was revoked, effective March 2, 2004.

This notice is issued and published under § 601.8 and the redelegation at SMG 1410.203.