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  1. Domestic MOUs

MOU 225-26-006

PARTNERSHIP AGREEMENT BETWEEN U.S. FOOD AND DRUG ADMINISTRATION AND CALIFORNIA DEPARTMENT OF PUBLIC HEALTH – FOOD AND DRUG BRANCH

I. PURPOSE

This Partnership Agreement (PA) is entered into by the California Department of Public Health – Food and Drug Branch (CDPH) and the United States Department of Health and Human Services, (DHHS), Food and Drug Administration’s (FDA) Office of Inspections and Investigations (OII), Office of Import Operations (OIO), Division of West Coast Imports (DWCI) (hereinafter referred to as “the Partners”).

The purpose of this agreement is to formalize the Partners’ mutual commitment to coordinate protection efforts of drugs, medical devices, and biological products in support of their respective public health and consumer protection missions. This PA applies to imported commodities regulated by the Partners and will support enforcement of respective Federal and State laws i.e. Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. § 301 et seq.) and the Public Health Service Act (42 U.S.C. § 262).
This PA does not affect or supersede any existing agreements, arrangements, contracts, or cooperative agreements between the partners and does not affect the ability of the partners to enter into other agreements or arrangements related to this PA.

II. DURATION

This agreement covers a period of five (5) years from the date of latest signature below. This time frame will give the Partners sufficient time to measure the PA outcomes, modify the PA if warranted, and renew the PA with consent of the Partners. This PA is effective when fully executed by the Partners through signing and shall remain in effect until termination by any Partner upon thirty (30) days advance written notice to the other Partner(s).

III. DEFINITIONS AND ACRONYMS

CDPH

California Department of Public Health – Food and Drug Branch

C.F.R.

Code of Federal Regulations

DID

Division of Information Disclosure

DWCI

Division of West Coast Imports

FDA

U.S. Food and Drug Administration

IFE

International Federal and Engagement Group

IMPSS

Integrated Medical Products Safety System

OII

Office of Inspections and Investigations

OIO

Office of Import Operations

PA

Partnership Agreement

POC

Point of Contact

SME

Subject Matter Expert

The Partners

FDA/OIO/DWCI and CDPH

U.S.C.

United States Code

IV. GOALS, OBJECTIVES, AND INTENDED OUTCOMES

The Partners are committed to pursuing the vision of an Integrated Medical Product Safety System (IMPSS) by coordinating efforts in support of the Partners’ public health missions, with an initial goal to support regulatory oversight of imported medical products for which each Partner has statutory responsibilities. The intent is to minimize duplicative efforts, strengthen each other’s knowledge and expertise, and leverage Partner’s regulatory resources towards a more effective, coordinated, and harmonized regulatory framework.

Furthering an IMPSS will allow for more efficient and effective use of resources and collaboration on risk-informed decision-making about activities that may be carried out by either Partner. Partners seek to enhance regulatory cooperation, improve coordination, and increase reliance on each other for follow-up and coordination when a regulatory concern arises. The Partners will benefit from leveraging each other’s resources to improve industry compliance with regulatory requirements, with a goal of improving public health and consumer protection.

Collaborative work and resource optimization will emphasize:

A. Legal Authority for Information Sharing and Protection of Public Health
B. Enhance and Coordinate Investigatory Communication and Regulatory Activities
C. Training
D. Industry and Community Relations
E. General Activities

V. RESPONSIBILITIES

A. Legal Authority for Information Sharing and Protection of Public Health.

  1. The Partners will utilize legally recognized agreements, such as information disclosure agreements pursuant to 21 C.F.R. § 20.88, to better coordinate information sharing, such as:
    1. Critical information about emergencies, recalls, product sampling, inspectional findings, and surveillance work (obtained under section 801 of the Act);
    2. Information on emerging situations for which partners have jurisdiction;
    3. Anticipated risk-based priorities; and
    4. Conditions and procedures outlining requirements for CDPH to consult with FDA DID prior to sharing or disclosing any FDA provided information or documents.

B. Enhance and Coordinate Investigatory Communication and Regulatory Activities:

The increasingly global nature of imported commodities necessitates the use of risk-analysis principles in decision-making to address threats to public health, facilitate FDA and state-regulated commodity protection, and strengthen imported product supply chain security. This PA is intended to enhance regulated product safety through activities that may encompass but are not limited to:

  1. conducting and coordinating joint regulatory operations to reduce duplication of efforts and leverage each other’s regulatory and enforcement authorities for greater protection of public health;
  2. clarifying regulatory roles;
  3. optimizing use of personnel, equipment, and facilities to ensure rapid sharing of critical information;
  4. providing regulatory, laboratory, and compliance operational support, pending resource availability;
  5. identifying potential issues or roadblocks, and developing strategies to minimize and prevent public health, regulatory, and compliance risks and challenges; and
  6. enhancing electronic communication tools.

The Partners will provide technical assistance and support, upon request and subject to availability.

C. Training:

To enhance proficiency and competency of staff members in partnering agencies, Partners will provide technical expertise and training for State and Federal regulatory personnel, as requested and subject to availability. Activities may encompass but are not limited to:

  1. leveraging training resources to enhance operation uniformity, competence, communication, and cooperation;
  2. leveraging State and FDA training resources and materials, when possible;
  3. notifying Partners of upcoming training courses/opportunities;
  4. sharing available training resources;
  5. integrating training faculty, when feasible, to best utilize expertise and increase communication and mutual understanding; and
  6. providing on-the-job training and shadowing opportunities.

D. Industry and Community Relations:

Excluding exchange of nonpublic information, Partners will work to integrate academics, regulatory science and knowledge to:

  • help industry comply with FDA laws and regulations;
  • promote community public health knowledge;
  • enhance supply chain security of imported products; and
  • provide notification of emerging public health issues.

E. General Activities

Activities may focus on drugs, medical devices, and biological products regulated by FDA and the State and associated programs, including but not limited to priority activities listed below;

  1. import safety related to pathogens, contaminants, and toxins;
  2. regulations, regulatory science, and policies throughout the supply chain;
  3. risk management and consumer behavior;
  4. imported unapproved and counterfeit drug interdiction efforts; and
  5. community outreach to alert, provide education and notifications of public health issues.
  6. the Partners understand the importance of leveraging resources to increase effectiveness and share mutual interest in collaborating on information sharing, evaluation activities, prevention, detection, and response activities that directly impact medical product safety and public health.

VI. LEGAL STATUS

No consideration has been given or received by either Partner to this PA. This PA is not legally binding and does not constitute a promise on the part of either Partner for performance. It does not create a legally enforceable contract, and the Partners agree that no remedies at law or equity will be sought by either Partner for non-performance of this PA. It does not impose additional legal duties, rights, benefits, or responsibilities, or remedies of either the Partners or of a third party. This PA imposes no duty on either Partner to act or to refrain from acting.

VII. INFORMATION DISCLOSURE

Access to non-public information, where appropriate, shall be governed by separate Information Sharing Agreements in accordance with 21 C.F.R. § 20.88 (20.88 agreement). Partners shall contact Office of the Commissioner, Division of Information Disclosure (DID) via email to FDAinfoshare@fda.hhs.gov to confirm the applicability of an existing
20.88 agreement, to enter into a 20.88 agreement, and prior to sharing any FDA-provided information.

VIII. ASSESSMENT AND EVALUATION

This PA may be amended or modified by mutual consent of the Partners in writing. The Partners will review the PA and goals annually.

The Partners will collaborate with OII/International and Federal Engagement (IFE) Subject Matter Experts to identify, establish, and monitor key metrics for performing an annual evaluation of the PA.

The Partners will make all reasonable attempts to meet, at a minimum annually, to discuss the current PA, metrics, evaluate the PA’s usefulness, and make modifications to the PA as needed. During the annual review and evaluation meeting, the Partners will jointly prepare options for follow-up. If new areas for developing PA activities are identified and agreed upon, this PA may be revised to reflect them. An updated PA may be submitted for consideration and approval by the signatories of this PA prior to annual renewal.

IX. STATEMENT OF NO FINANCIAL OBLIGATIONS

Signature of this PA does not constitute a financial obligation on the part of FDA or CDPH. Each Partner will use and manage its own funds in carrying out the purpose of this PA. Permanent transfers of funds or items of value is not authorized under this PA.

X. RESOURCES

ACTIVITY LIAISON OFFICIALS:

International and Federal Engagement POC:
Tammy Vasquez Hancock, CSO, IFE

FDA Partner POCs:
CAPT Nazmul Hassan, Acting Assistant Commissioner, OIO
Kathleen Turner, DVM, Program Division Director, DWCI
Gordon Chu, Director of Investigations Branch DWCI
Marissa Chan, Supervisor DWCI
Jessica Lee, Supervisor DWCI

State Partner POC:
James Chan, Chief, CDPH Food and Drug Branch
June-Mei Han, Chief, CDPH Food and Drug Branch, Drug and Medical Device Compliance and Enforcement Section

XI. CONCLUSIONS AND RECOMMENDATION

The Partners agree to the provisions in this PA.

ENDORSEMENTS

(SIGNATORIES OF RESPONSIBLE PARTIES MUST INCLUDE PRINTED NAME, SIGNED NAME AND DATE OF SIGNATURE)

Approved and Accepted for the U.S. Food and Drug Administration:

/s/
Elizabeth Miller
Associate Commissioner
FDA Office of Inspections and Investigations
Date: 07/21/2026

/s/
CAPT Nazmul Hassans
Acting Assistant Commissioner
FDA Office of Inspections and Investigations
Office of Import Operations
Date: 07/10/2026

/s/
Kathleen Turner, DVM
Division Director
FDA Office of Inspections and Investigations
Office of Import Operations, Division of West Coast Imports 

Accepted for the California Department of Public Health - Food and Drug Branch:

/s/
David Mazzera, PhD
Chief, Division of Food and Drug Safety
California Department of Public Health - Food and Drug Branch
Date: 06/30/2026

/s/
James Chan
Chief, Food and Drug Branch
California Department of Public Health - Food and Drug Branch
Date: 6/30/2026

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