[Federal Register Volume 88, Number 148 (Thursday, August 3, 2023)]
[Notices]
[Pages 51328-51330]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. An application 
submitted electronically, including attachments, to https://www.regulations.gov 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 https://www.regulations.gov.
     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

     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.
     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 https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket, go to https://www.regulations.gov 
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 [email protected].

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