Inspections, Compliance, Enforcement, and Criminal Investigations

08/28/1997

[Federal Register: August 28, 1997 (Volume 62, Number 167)]
[Notices]
[Page 45667-45668]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28au97-82]


DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0256]

Norma D. Banks; Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Norma D. Banks, 3688 West Minarets Ave., Fresno, CA 91331, from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Ms. Banks was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the act. Ms. Banks has failed to request a hearing and, therefore, has waived her opportunity for a hearing concerning this action.

EFFECTIVE DATE: August 28, 1997.
ADDRESSES: Application for termination of debarment to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Leanne Cusumano, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION:

  1.  Background

    Ms. Banks was employed by H. R. Cenci Laboratories, Inc. (Cenci), as Director of Quality Assurance and Regulatory Affairs. In that capacity, on November 17, 1993, she knowingly and willfully made false, fictitious, and fraudulent representations in a matter within the urisdiction of FDA. Specifically, she misrepresented to FDA's Office of Generic Drugs information contained in an annual report that stability tests for three drug products manufactured by H. R. Cenci Laboratories, Inc. (i.e., promethazine syrup with phenylephrine, promethazine syrup with codeine, and promethazine syrup with phenylephrine and codeine), were uniformly passing, when, in fact, several stability test results were failing.

    On January 25, 1996, the United States District Court for the District of Maryland entered judgment against Ms. [[Page 45668]] Banks for one count of knowingly and willfully making false, fictitious, and fraudulent statements and representations to a Federal agency as to material facts, a Federal felony under 18 U.S.C. 1001.

    As a result of this conviction, FDA served Ms. Banks by certified mail on September 26, 1996, a notice proposing to permanently debar her from providing services in any capacity to a person that has an approved or pending drug product application, and offered her an opportunity for a hearing on the proposal. The proposal was based on a finding, under section 306(a)(2)(B) of the act (21 U.S.C. 335a(a)(2)(B)), that Ms. Banks was convicted of a felony under Federal law for conduct relating to the regulation of a drug product. Ms. Banks did not request a hearing. Her failure to request a hearing constitutes a waiver of her opportunity for a hearing and a waiver of any contentions concerning her debarment.

  2. Findings and Order

    Therefore, the Director, Center for Drug Evaluation and Research, under section 306(a) of the act, and under authority delegated to her (21 CFR 5.99(b)), finds that Ms. Norma D. Banks has been convicted of a felony under Federal law for conduct relating to the regulation of a drug product.

    As a result of the foregoing finding, Ms. Norma D. Banks is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application under section 505, 507, 512, or 802 of the act (21 U.S.C. 355, 357, 360b, or 382), or under section 351 of the Public Health Service Act (42 U.S.C. 262), effective August 28, 1997 (sections 306(c)(1)(B) and (c)(2)(A)(ii) and 201(dd) of the act (21 U.S.C. 321(dd)). Any person with an approved or pending drug product application who knowingly uses the services of Ms. Banks in any capacity, during her period of debarment, will be subject to civil money penalties (section 307(a)(6) of the act (21 U.S.C. 335b(a)(6))). If Ms. Banks, during her period of debarment, provides services in any capacity to a person with an approved or pending drug product application, she will be subject to civil money penalties (section 307(a)(7) of the act). In addition, FDA will not accept or review any abbreviated new drug applications or abbreviated antibiotic drug applications submitted by or with the assistance of Ms. Banks during her period of debarment.

    Any application by Ms. Banks for termination of debarment under section 306(d)(4) of the act should be identified with Docket No. 96N-0256 and sent to the Dockets Management Branch (address above). All such submissions are to be filed in four copies. The public availability of information in these submissions is governed by 21 CFR10.20(j). Publicly available submissions may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

Dated: August 12, 1997.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 97-22856 Filed 8-27-97; 8:45 am]
BILLING CODE 4160-01-F

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