Notice2023-16550
Raidel Figueroa: Final Debarment Order
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 3, 2023
Effective
August 3, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Raidel Figueroa 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. Figueroa was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Figueroa was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why he should not be debarred within the timeframe prescribed by regulation. Mr. Figueroa has not responded to the notice. Mr. Figueroa's failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of his right to a hearing concerning this action.
Full Text
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<title>Federal Register, Volume 88 Issue 148 (Thursday, August 3, 2023)</title>
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[Federal Register Volume 88, Number 148 (Thursday, August 3, 2023)]
[Notices]
[Pages 51328-51330]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-16550]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2175]
Raidel Figueroa: Final 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 Raidel Figueroa 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. Figueroa was
convicted of a felony under Federal law for conduct that relates to the
regulation of a drug product under the FD&C Act. Mr. Figueroa was given
notice of the proposed permanent debarment and was given an opportunity
to request a hearing to show why he should not be debarred within the
timeframe prescribed by regulation. Mr. Figueroa has not responded to
the notice. Mr. Figueroa's failure to respond and request a hearing
within the prescribed timeframe constitutes a waiver of his right to a
hearing concerning this action.
DATES: This order is effective August 3, 2023.
ADDRESSES: Any application by Mr. Figueroa for special termination of
debarment under section 306(d)(4) of the FD&C Act (21 U.S.C.
335a(d)(4)) may be submitted as follows:
Electronic Submissions
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. An application
submitted electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> will be posted to the docket unchanged. Because
your application will be made public, you are solely responsible for
ensuring that your application does not include any confidential
information that you or a third party may not wish to be posted, such
as medical information, your or anyone else's Social Security number,
or confidential business information, such as a manufacturing process.
Please note that if you include your name, contact
[[Page 51329]]
information, or other information that identifies you in the body of
your application, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit an application with confidential
information that you do not wish to be made available to the public,
submit the application as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For a written/paper application submitted to the Dockets
Management Staff, FDA will post your application, as well as any
attachments, except for information submitted, marked, and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All applications must include the Docket No. FDA-
2022-N-2175. Received applications will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit an application with
confidential information that you do not wish to be made publicly
available, submit your application only as a written/paper submission.
You should submit two copies total. One copy will include the
information you claim to be confidential with a heading or cover note
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The
Agency will review this copy, including the claimed confidential
information, in its consideration of your application. The second copy,
which will have the claimed confidential information redacted/blacked
out, will be available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Submit both copies to the Dockets Management
Staff. Any information marked as ``confidential'' will not be disclosed
except in accordance with 21 CFR 10.20 and other applicable disclosure
law. For more information about FDA's posting of comments to public
dockets, see 80 FR 56469, September 18, 2015, or access the information
at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
and insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852 between 9 a.m. and 4 p.m., Monday through Friday, 240-402-
7500. Publicly available submissions may be seen in the docket.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of Compliance
and Enforcement, Office of Policy, Compliance, and Enforcement, Office
of Regulatory Affairs, Food and Drug Administration, at 240-402-8743,
or <a href="/cdn-cgi/l/email-protection#9bfffef9fae9f6fef5efe8dbfdfffab5f3f3e8b5fcf4ed"><span class="__cf_email__" data-cfemail="9efafbfcffecf3fbf0eaeddef8faffb0f6f6edb0f9f1e8">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(B) of the FD&C Act requires debarment of an
individual from providing services in any capacity to a person that has
an approved or pending drug product application 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
August 31, 2022, Mr. Figueroa was convicted in the U.S. District Court
for the Southern District of Florida, Fort Lauderdale Division, when
the court entered a judgment of conviction, after his plea of guilty,
to one count of conspiracy to defraud the United States in violation of
18 U.S.C. 371, one count of falsification of records in a Federal
investigation in violation of 18 U.S.C. 1519, one count of obstruction
of proceedings before an Agency of the United States in violation of 18
U.S.C. 1505, and one count of distribution of adulterated drugs in
interstate commerce in violation of 21 U.S.C. 331(a) (section 301(a) of
the FD&C Act), all felony offenses under Federal law.
The factual basis for this conviction is as follows: Mr. Figueroa
was the Chief Executive Officer and co-owner of Pharmatech, LLC, a drug
and dietary supplement manufacturer that operated in Broward County,
FL. From at least 2016 through at least March 2017, Pharmatech
manufactured and distributed Diocto Liquid, a drug used to treat
constipation in adults and children. In July 2016, FDA initiated an
inspection at Pharmatech as part of an investigation into an outbreak
of Burkholderia cepacia (B. cepacia) infections. B. cepacia is the name
for a group or ``complex'' of bacteria typically found in soil and
water. These bacteria pose little medical risk to healthy people, but
people who have certain health problems like weakened immune systems or
chronic lung diseases may be more susceptible to B. cepacia infections.
The effects of B. cepacia can include serious respiratory infections
and other types of infections. Contaminated medicines can transmit B.
cepacia, and the bacteria are often resistant to common antibiotics. At
the close of FDA's inspection in August of 2016, FDA notified Mr.
Figueroa that a water sample taken from Pharmatech's water system had
tested positive for the presence of B. cepacia. In his written response
to FDA's inspectional observations, Mr. Figueroa advised FDA that
Pharmatech was re-engineering its purified water system to prevent
contamination of the water used for both production and cleaning
purposes. Following the July-August 2016 FDA inspections, Mr. Figueroa
also temporarily stopped manufacturing liquid products.
In March 2017, FDA initiated another inspection at Pharmatech. FDA
investigators asked Mr. Figueroa to provide a product list of all
products that Pharmatech had manufactured after it resumed
manufacturing in November 2016. Mr. Figueroa knowingly excluded Diocto
Liquid from Pharmatech's products list that he provided FDA
investigators despite Pharmatech having shipped approximately 7,308
units of the drug earlier that month. When FDA investigators later
discovered that the product list Mr. Figueroa provided them was
incomplete, FDA investigators again requested he provide them with a
complete list. Mr. Figueroa caused a second product list to be produced
to FDA; he again falsely represented to FDA that it was a complete list
when he knew it was false because it omitted Diocto Liquid.
In April 2017, Mr. Figueroa provided FDA a written memorandum
regarding Pharmatech's water system. That memorandum falsely stated
that all data for Phase 3 testing of Pharmatech's new water system had
met ``acceptance criteria,'' although Mr. Figueroa was aware the water
system had not met acceptance criteria because a water sample taken on
February 15, 2017, tested presumptive positive for the presence of B.
cepacia.
During this same March-May 2017 inspection, when FDA investigators
requested that Mr. Figueroa identify any other business he owned, he
failed to disclose that he owned and controlled Ofcus Pharma, which was
a company established for the purpose of manufacturing oral solid drugs
and dietary supplements. Mr. Figueroa later asked someone else to tell
FDA investigators that they were the owner of Ofcus Pharma if that firm
was ever inspected by FDA, and not to disclose that Mr. Figueroa was
the owner of Ofcus Pharma.
[[Page 51330]]
In July 2017, the Centers for Disease Control and Prevention
notified FDA of multiple cases of B. cepacia infections in pediatric
patients at Stanford Children's Health Lucile Packard Children's
Hospital in Palo Alto, CA and Johns Hopkins Children's Center in
Baltimore, MD. FDA investigated and collected bottles of Diocto Liquid
from these medical centers. The collected bottles were from the same
lot that Pharmatech distributed in March 2017--the same lot that
Pharmatech failed to disclose to FDA. Several of the bottles contained
total aerobic microbial counts and total yeast and mold counts in
excess of acceptable limits and some of the bottles also tested
positive for the presence of B. cepacia.
In September 2017, FDA initiated an inspection of Ofcus Pharma.
During that inspection the individual Mr. Figueroa asked to
misrepresent to FDA that they owned Ofcus Pharma, did in fact make
false statements to an FDA investigator when they told the investigator
they had full ownership of Ofcus Pharma.
Based on this conviction, FDA sent Mr. Figueroa by certified mail
on March 20, 2023, a notice 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 a finding,
under section 306(a)(2)(B) of the FD&C Act, that Mr. Figueroa was
convicted, as set forth in section 306(l)(1) of the FD&C Act, of a
felony under Federal law for conduct relating to the regulation of a
drug product under the FD&C Act. The proposal also offered Mr. Figueroa
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 file a timely request for a hearing would
constitute an election not to use the opportunity for a hearing and a
waiver of any contentions concerning this action. Mr. Figueroa received
the proposal on March 30, 2023. He did not request a hearing within the
timeframe prescribed by regulation and has, therefore, waived his
opportunity for a hearing and any contentions concerning his debarment
(21 CFR part 12).
II. Findings and Order
Therefore, the Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(a)(2)(B) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Mr.
Figueroa has been convicted of a felony under Federal law for conduct
relating to the regulation of a drug product under the FD&C Act.
As a result of the foregoing finding, Mr. Figueroa is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application, effective (see DATES)
(see sections 306(a)(2)(B) and (c)(2)(A)(ii) of the FD&C Act). Any
person with an approved or pending drug product application who
knowingly employs or retains as a consultant or contractor, or
otherwise uses in any capacity the services of Mr. Figueroa 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. Figueroa 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). In
addition, FDA will not accept or review any abbreviated new drug
application from Mr. Figueroa during his period of debarment, other
than in connection with an audit under section 306 of the FD&C Act
(section 306(c)(1)(B) of the FD&C Act). Note that, for purposes of
sections 306 and 307 of the FD&C Act, a ``drug product'' is defined as
a ``drug subject to regulation under section 505, 512, or 802 of this
Act [(21 U.S.C. 355, 360b, 382)] or under section 351 of the Public
Health Service Act [(42 U.S.C. 262)]'' (section 201(dd) of the FD&C Act
(21 U.S.C. 321(dd))).
Dated: July 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16550 Filed 8-2-23; 8:45 am]
BILLING CODE 4161-01-P
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