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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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12/30/1994

[Federal Register: December 30, 1994]

 

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Food and Drug Administration

[Docket No. 93N-0462]

 

Abu Quamruzzaman; Debarment Order

 

AGENCY: Food and Drug Administration, HHS.

 

ACTION: Notice.

 

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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.

 

SUPPLEMENTARY INFORMATION:

 

I. Background

    

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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