Summary
Overview
Work History
Education
Skills
Awards History
Education Training Professional Development
Performance
Timeline
Generic

Kristen Jackson

Ridgewood

Summary

Compliance officer with extensive experience in regulatory compliance and FDA policies. Proven ability to interpret and communicate complex laws and regulations effectively. Skilled in developing compliance cases and fostering a culture of integrity and efficiency. Track record of ensuring smooth operational flow and implementing successful enforcement strategies.

Overview

23
23
years of professional experience

Work History

Compliance Officer, Human Foods Program, Emerging Issues Branch

US Food and Drug Administration
Parsippany
10.2024 - 08.2025

Duties & Responsibilities:
• Works closely with Federal, State Local and International agencies to implement enforcement actions
related to nationwide foodborne illness outbreak investigations, working to ensure that the sources of these outbreaks are identified, that food is removed from the market, the root cause identified, and appropriate actions prevent recurring.
• Supervises employees in the EIB by assigning, monitoring and working with them to drive enforcement on fast moving situations where thinking outside of the box is needed to immediately address a serious and egregious situation where the nation's food supply is safe.

Impact/Accomplishments:
• Implemented the only food facility suspension in 2024, legally preventing the firm (which
manufactured adulterated food for nationwide dessert brands) from shipping adulterated food,
developing an injunction for the same firm, and implementing other legal actions.

  • Ensured compliance with FDA regulations and guidelines for diverse product categories, mitigating risks associated with non-compliance.
  • Reviewed and analyzed regulatory submissions for accuracy and completeness, facilitating timely approvals and reducing potential delays.
  • Conducted audits to assess adherence to compliance standards and protocols, identifying areas for improvement and reinforcing regulatory adherence.

Compliance Officer, CFSAN

Food And Drug Administration
Ridgewood
10.2016 - 10.2024

Duties & Responsibilities:

• Evaluates the adequacy of evidence from FDA, as well state, local and foreign governments to determine the safety of the food manufactured, processed, packed and imported into the country for consumption.

• Determines approval or disapproval of recommended regulatory action from field officials based on policy and significance according to laws, regulations, policies and established precedents.

• Assists the Office of Chief Counsel, Department of Justice, field Compliance Officers and US Attorney Generals in removing unsafe food products from the market and ensuring that firms do not process, manufacture, pack or import food that is not fit for consumption.

Developed enforcement strategies for Compliance Programs in collaboration with program offices to enhance public health nationwide.

• Works closely with FDA experts, industry and CDC to immediately react to multi-state outbreaks involving human illnesses related to foodborne illnesses, both with domestic and imported products.

Impact/Accomplishments:

• Completed a number of regulatory actions that have mitigated the number of unsafe food products from entering commerce, worked on a number of cases with the field offices to bring non-compliant food manufacturers into compliance reducing the amount of unsafe food being sold to the public, as well as provided contributions to bring consistency and uniformity to future nation-wide assignments that will be issued in the upcoming year to identify emerging public health issues that have a direct impact on the public health, specifically focusing on food that is typically consumed by young children.

• Was part of a workgroup that had to evaluate and justify regulatory action for findings of extremely high levels of per- and polyfluoroalkyl substances (PFAS/PFOAs, newly identified ‘forever chemicals’ identified by the EPA and CDC as hazardous) in foreign canned clams that were imported into the US for consumption; to date the FDA does not have any guidance on acceptable levels of chemicals, however the levels were so concerning that it was necessary to remove the product from the market.

• Working on an ongoing case that involves extremely high levels of lead in cinnamon applesauce pouches that are marketed to children. Working closely with policy and legal experts, we were able to quickly identify the product and source and initiated actions to stop the importation, initiate a nationwide recall, initiate a foreign inspection of the manufacture, and determine the cause. To date this case has resulted in over 251 children from 34 states with acute lead poisoning nationwide, and had action not been taken could have affected many more.

• Worked on one of the first Preventive Controls Warning Letter that was the result of a nation-wide recall of a food product that was contaminated with a pathogen in a popular food brand consumed typically by children

• Worked on a number of foodborne outbreak responses and post-response activities in conjunction with CORE (Coordinated Outbreak Response and Evaluation Group).. The response activities assess and address the ongoing outbreak to determine the source and root causes where possible. The post-response activities preventive strategies are developed to minimize future public health threats.

• Primary compliance officer involved in the yearlong investigation regarding elevated lead in cinnamon applesauce pouches from Ecuador impacting 400+ children that were found to have acute lead poisoning. This work contributed to multiple import alert listings preventing adulterated food from US commerce.

Compliance Officer, New York District

Food And Drug Administration
Jamaica
02.2009 - 10.2016

Duties & Responsibilities:
• Review and follow up with non-compliance establishments and seek voluntary compliance in both Domestic and Import issues.
• Review and evaluate evidence to resolve the final status of products under the FDC Act and the most
appropriate course of action in order to bring the object into compliance or if it must be exported or destroyed.
• Interact with Federal and State agencies as well as industry, to exchange information and provide guidance in regards to situations where there are deficiencies and facilitate the compliance of violative products offered for
import.
• Review industry inspection reports and communication to determine if a facility is in compliance with
regulations; if necessary issue follow up assignments, Warning Letters, and initiate other regulatory action where needed.
• Review and initiate legal resources with firms who do not comply with the FDC Act; this includes permanent injunctions of the firms and their management, seizures and civil money penalties that are coordinated with the Department of Justice and the local Federal District Courts.


Impact/Accomplishments:
• Initiated and successfully issued an Order of Suspension of Food Facility Registration, only the third time the FDA has utilized this authority, to prevent a food firm from distributing food products that the FDA considered to be contaminated with Listeria monocytogenes; thereby preventing the public from consuming these
adulterated products.
• Initiated one and monitored an additional nine firms that are operating under Consent Decrees of Permanent Injunction; this included initiating the District's first Consent Decree of Permanent Injunction of a Dietary Supplement firm for failing to meet good manufacturing practices as well as making false and misleading claims on their product labels.
• Initiated and executed New York District's first open-ended seizure of dietary supplement products for false and misleading claims, this was the result of a meeting with a US Federal Judge and coordinating the seizure with the United States Marshalls.

  • Monitored compliance with federal food and drug safety regulations, ensuring adherence to standards that protect public health.
  • Conducted audits to verify compliance with industry standards and guidelines, identifying areas for improvement and facilitating corrective actions.
  • Reviewed regulatory submissions for accuracy and completeness of documentation, ensuring all materials met required compliance criteria.

Consumer Safety Officer, New York District Office

Food And Drug Administration
Jamaica
09.2002 - 02.2009

Duties & Responsibilities:

• Review, investigate, and initiate regulatory action on entries and products introduced for import through the various ports of New York District.

Inspected and investigated foods, drugs, cosmetics, medical devices, and radiation-emitting devices, reviewing paperwork and conducting physical exams to ensure compliance with FDA regulations.

• Conduct Seafood HACCP inspection on seafood processors and importers throughout the New York Downstate District area.

• Worked in conjunction with other federal agencies at the IMF at JFK International Airport in screening and detaining unapproved new drugs as well as counterfeit drugs.

Collected aseptic physical samples for laboratory analysis.

Impact/Accomplishments

• Active role in Operation Bait and Switch, which was conducted with Customs and Border Patrol and Drug Enforcement Agency to determine which countries were involved with a Canadian on-line pharmacy to determine quality, integrity and potency of the pharmaceuticals.

• Helped to coordinate our office, as well as participated, in Food Security Surveillance Assignment (FSSA) which was created due to the National Election of 2004, the G8 Summit, and the Democratic and Republican Conventions.

Education

Bachelor of Science - Environmental Health Science

Eastern Kentucky University
01-2002

Skills

  • Regulatory compliance
  • Import/export compliance
  • Risk assessment
  • Evidence evaluation
  • stakeholder engagement
  • problem solving
  • effective communication
  • team leadership
  • Risk assessment

Awards History

  • USPHS Individual Honor Award - USPHS Commendation Medal, 2010
  • Unit Award - Unit Commendation, 2021, 2012, 2010, 2006, 2004
  • USPHS Service/Training Awards, 2020, 2008, 2002
  • FDA - Commissioner's Special Citation, 2004
  • Presidential Unit Citation, 2016
  • FDA Honor Award, 2023

Education Training Professional Development

(see Continuing Education Sheet attached)

Performance

  • Led workgroups drafting new processes and procedures for the new Human Foods Program (HFP) ensuring a seamless and successful reorganization
  • Primary compliance officer involved in the yearlong investigation regarding elevated lead in cinnamon applesauce pouches from Ecuador impacting 400+ children that were found to have acute lead poisoning. This work contributed to multiple import alert listings preventing adulterated food from US commerce.
  • Enforcement Lead for the Poppyseed Workgroup to identify limits and guidance for the safe consumption of poppyseeds.
  • Active member of Division of Enforcements Chemical Contaminate Team, working to reduce the levels of contaminates, including heavy metals, PFAS/PFOAs and pesticides, in food products.
  • FDA Honor Award 2023 Food Traceability Regulation Team
  • Unit Commendation 2021 - for UC Apollo Mission in Houston TX

Timeline

Compliance Officer, Human Foods Program, Emerging Issues Branch

US Food and Drug Administration
10.2024 - 08.2025

Compliance Officer, CFSAN

Food And Drug Administration
10.2016 - 10.2024

Compliance Officer, New York District

Food And Drug Administration
02.2009 - 10.2016

Consumer Safety Officer, New York District Office

Food And Drug Administration
09.2002 - 02.2009

Bachelor of Science - Environmental Health Science

Eastern Kentucky University

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Kristen Jackson