Inspections, Compliance, Enforcement, and Criminal Investigations
[Federal Register: December 30, 1994]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 93N-0462]
Abu Quamruzzaman; Debarment Order
AGENCY: Food and Drug Administration, HHS.
SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under section 306(a)(2) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 335a(a)(2)) permanently debarring Mr. Abu
Quamruzzaman, 178-10 Wexford Ter., Jamaica, NY 11432, 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 Mr.
Quamruzzaman was convicted of a felony under Federal law for conduct
relating to the development or approval, including the process for
development or approval, of a drug product; and relating to the
regulation of a drug product under the act. Mr. Quamruzzaman has
notified FDA that he acquiesces to debarment and, therefore, has waived
his opportunity for a hearing concerning this action.
EFFECTIVE DATE: November 18, 1993.
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: Tamar S. Nordenberg, Center for Drug
Evaluation and Research (HFD-366), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-2041.
Mr. Abu Quamruzzaman, a former Vice President of Quality Affairs of
Biopharmaceutics, Inc. (Biopharmaceutics), pled guilty and was
sentenced on October 14, 1993, for making a false statement in a matter
within the jurisdiction of a Federal agency, a Federal felony offense
under 18 U.S.C. 1001. The basis for this conviction was Mr.
Quamruzzaman's material false statements made in an abbreviated
antibiotic drug application, prepared by him for submission to FDA, for
Biopharmaceutics' product Clindamycin Hydrochloride 150-milligram
capsules. The material falsehoods included misrepresentations (1) about
the batches from which samples were submitted for human bioequivalency
testing and stability testing and (2) about in-process tests that were
not conducted during the manufacturing process as required, but rather
were conducted later using product samples stored in bulk.
Mr. Abu Quamruzzaman is subject to debarment based on a finding,
under section 306(a) of the act, that he was convicted of a felony
under Federal law for conduct relating to the development, approval,
and regulation of a drug product. In a letter dated November 18, 1993,
Mr. Quamruzzaman notified FDA of his acquiescence to debarment, as
provided for in section 306(c)(2)(B) of the act. While a person subject
to debarment is entitled to an opportunity for an agency hearing on
disputed issues of material fact under section 306(i) of the act, Mr.
Quamruzzaman, by acquiescing to debarment, waived his right to an
opportunity for a hearing and any contentions concerning his debarment.
II. Findings and Order
Therefore, the Interim Deputy Commissioner for Operations, under
section 306(a) of the act, and under authority delegated to her (21 CFR
5.20), finds that Mr. Abu Quamruzzaman has been convicted of a felony
under Federal law for conduct relating to the development or approval,
including the process for development or approval, of a drug product
(21 U.S.C. 335a(a)(2)(A)); and relating to the regulation of a drug
product (21 U.S.C. 335a(a)(2)(B)).
As a result of the foregoing findings and based on his notification
of acquiescence, Mr. Abu Quamruzzaman 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 November 18, 1993,
the date of notification of acquiescence (21 U.S.C. 335a(c)(1)(B) and
(c)(2)(A)(ii) and 21 U.S.C. 321(ee)). Any person with an approved or
pending drug product application who knowingly uses the services of Mr.
Quamruzzaman, in any capacity, during his period of debarment, will be
subject to civil money penalties. If Mr. Quamruzzaman, during his
period of debarment, provides services in any capacity to a person with
an approved or pending drug product application, he will be subject to
civil money penalties. In addition, FDA will not accept or review any
abbreviated new drug applications submitted by or with the assistance
of Mr. Quamruzzaman during his period of debarment.
Any application by Mr. Quamruzzaman for termination of debarment
under section 306(d)(4) of the act should be identified with Docket No.
93N-0462 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 CFR
10.20(j). Publicly available submissions may be seen in the Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Dated: December 20, 1994.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 94-32140 Filed 12-29-94; 8:45 am]
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