[Federal Register Volume 80, Number 119 (Monday, June 22, 2015)]
[Notices]
[Pages 35652-35653]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15162]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0097]


Mirwaiss Aminzada: 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 the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 
permanently debarring Mirwaiss Aminzada 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. Aminzada was 
convicted of a felony under Federal law for conduct relating to the 
regulation of a drug product. Mr. Aminzada was given notice of the 
proposed permanent debarment and an opportunity to request a hearing 
within the timeframe prescribed by regulation. Mr. Aminzada failed to 
request a hearing. Mr. Aminzada's failure to request a hearing 
constitutes a waiver of his right to a hearing concerning this action.

DATES: This order is effective June 22, 2015.

ADDRESSES: Submit applications for termination of debarment to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade (ELEM-4144), Office of 
Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Drive, 
Rockville, MD 20857, 301-796-4640.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B)) 
requires debarment of an individual if FDA finds that the individual 
has been convicted of a felony under Federal law for conduct relating 
to the regulation of any drug product under the FD&C Act.
    On June 10, 2014, the U.S. District Court for the Eastern District 
of Virginia entered judgment against Mr. Aminzada for one count of 
introducing misbranded drugs into interstate commerce with intent to 
defraud or mislead, in violation of sections 301(a) and 303(a)(2) of 
the FD&C Act (21 U.S.C. 331(a) and 333(a)(2)).
    FDA's finding that debarment is appropriate is based on the felony 
conviction referenced herein. The

[[Page 35653]]

factual basis for this conviction is as follows: Between around August 
2009 and August 2013, Mr. Aminzada owned and operated several companies 
dedicated to international sales, including Royal Canadian Imports 
(headquartered in Canada), and Essa Gulf Trading (headquartered in 
Dubai, United Arab Emirates).
    Between approximately August 2009 and August 2012, Mr. Aminzada 
sold misbranded chemotherapy drugs and injectable cosmetic drugs to 
Gallant Pharma International, Inc. (Gallant Pharma) for resale in the 
United States. Neither of Mr. Aminzada's companies were licensed as a 
prescription drug wholesaler anywhere in the United States. Mr. 
Aminzada admitted that the drugs he sold to Gallant Pharma for resale 
in the United States were prescription only, and that many of the drugs 
were misbranded in that the drugs did not bear adequate directions for 
use and were not subject to an exemption from that requirement, and 
were accompanied by non-FDA approved packaging and inserts, which were 
sometimes written in foreign languages. The drugs Mr. Aminzada sold to 
Gallant Pharma also lacked the FDA-required pedigree, which protects 
patients' health by tracking each sale, purchase, or trade of a drug 
from the time of manufacturing to delivery to the patient. Between 
August 2009 and August 2012, Mr. Aminzada received at least $586,798 in 
wire transfers from Gallant Pharma, representing revenues from sales of 
such drugs to Gallant Pharma. Mr. Aminzada admitted that his actions 
were in all respect knowing, voluntary, intentional, and did not occur 
by accident, mistake, or for another innocent reason.
    As a result of his conviction, on March 9, 2015, FDA sent Mr. 
Aminzada a notice by certified mail proposing to permanently debar him 
from providing services in any capacity to a person that has an 
approved or pending drug product application. The proposal was based on 
the finding, under section 306(a)(2)(B) of the FD&C Act, that Mr. 
Aminzada was convicted of a felony under Federal law for conduct 
related to the regulation of a drug product. FDA determined that Mr. 
Aminzada's felony conviction was related to the regulation of drug 
products because the conduct underlying his conviction undermined FDA's 
regulatory oversight over drug products marketed in the United States 
by intentionally introducing into interstate commerce drug products 
that did not bear adequate directions for use and were not subject to 
an exemption from that requirement, and which, among other things, were 
accompanied by non-FDA approved packaging and inserts. The proposal 
also offered Mr. Aminzada an opportunity to request a hearing, 
providing him 30 days from the date of receipt of the letter in which 
to file the request, and advised him that failure to request a hearing 
constituted a waiver of the opportunity for a hearing and of any 
contentions concerning this action. The proposal was received on March 
16, 2015. Mr. Aminzada failed to respond within the timeframe 
prescribed by regulation and has, therefore, waived his opportunity for 
a hearing and has waived any contentions concerning his debarment (21 
CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement and Import 
Operations, Office of Regulatory Affairs, under section 306(a)(2)(B) of 
the FD&C Act, under authority delegated to the Director (Staff Manual 
Guide 1410.35), finds that Mirwaiss Aminzada has been convicted of a 
felony under Federal law for conduct relating to the regulation of a 
drug product. Section 306(c)(2)(A)(ii) of the FD&C Act (21 U.S.C. 
335a(c)(2)(A)(ii)) requires that Mr. Aminzada's debarment be permanent.
    As a result of the foregoing findings, Mirwaiss Aminzada is 
permanently debarred from providing services in any capacity to a 
person with an approved or pending drug product application under 
sections 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 
382), or under section 351 of the Public Health Service Act (42 U.S.C. 
262), effective (see DATES) (see sections 201(dd), 306(c)(1)(B), and 
306(c)(2)(A)(ii) of the FD&C Act, (21 U.S.C. 321(dd), 335a(c)(1)(B), 
and 335a(c)(2)(A)(ii)). Any person with an approved or pending drug 
product application who knowingly employs or retains as a consultant or 
contractor, or otherwise uses the services of Mirwaiss Aminzada, in any 
capacity during his debarment, will be subject to civil money penalties 
(section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Mr. 
Aminzada provides services in any capacity to a person with an approved 
or pending drug product application during his period of debarment he 
will be subject to civil money penalties (section 307(a)(7) of the FD&C 
Act (21 U.S.C. 335b(a)(7))). In addition, FDA will not accept or review 
any abbreviated new drug applications submitted by or with the 
assistance of Mirwaiss Aminzada during his period of debarment (section 
306(c)(1)(A) of the FD&C Act (21 U.S.C. 335a(c)(1)(A))).
    Any application by Mr. Aminzada for special termination of 
debarment under section 306(d)(4) of the FD&C Act (21 U.S.C. 
335a(d)(4)) should be identified with Docket No. FDA-2015-N-0097 and 
sent to the Division of Dockets Management (see ADDRESSES). 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.
    Publicly available submissions may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 16, 2015.
Douglass Stearn,
Director, Division of Compliance Policy, Office of Enforcement, Office 
of Regulatory Affairs.
[FR Doc. 2015-15162 Filed 6-19-15; 8:45 am]
BILLING CODE 4164-01-P