With more than 500 facilities being cited last year for a faulty or missing FSVP and more remote & on-site inspections expected to resume shortly, it's time to dust-off your FSVP and get it in tip-top shape. Dr. Lily Yang from TAG explains how.

1. FSMA Fridays Webinar Series
Monthly Industry News, Updates & Trends for Food, Beverage, & CPG Manufacturers
Don't Get 483'd for Your FSVP
with Lily Yang, Ph.D., and Christopher Snabes, The Acheson Group
March 26, 2021

2. Monthly Industry Update:
✔FSMA Related News
✔Regulation Changes & Updates
✔Industry Trends
✔Q&A with TAG
What is FSMA Fridays?
FSMA FRIDAYS

3. Casual but Professional Format
✔Ask questions! (Q&A at end)
✔Only panelists are displayed
✔Recording link will be shared
✔Audio issues: use call-in number
Watch prior FSMA Friday recordings at
safetychain.com > Resources > FSMA Fridays
Before We Get Started
FSMA FRIDAYS

4. Featured Panelists
FSMA FRIDAYS
Aaron Bolshaw
VP Marketing
Lily Yang, Ph.D.
Food Safety Associate, The Acheson Group
● Food safety culture specialist focused on the impacts of
consumer and stakeholder attitudes, behaviors, and
technological utilization within the food system
● M.S. and Ph.D. in Food Science from Virginia Tech
Christopher Snabes, BS, MS, CFS
Director of Food Safety, The Acheson Group
● 18+ years food industry experience
● Degrees in microbiology and biology
● One of very few authorized Lead Instructors for the
Vulnerability Analysis component of food defense plans

5. FSMA FRIDAYS
The Latest FSMA Updates
1. FSMA’s 10th Anniversary: Ten years ago (April 1, 2011), the FDA Food Safety
Modernization Act (FSMA) was signed into law and Congress’ mandate was clear: “It’s not
enough to respond to outbreaks of foodborne illness. We must prevent them from
happening in the first place.”
2. VQIP Application Portal Now Open for FY 2022. On January 1, 2021, the U.S. Food and
Drug Administration (FDA) opened the Voluntary Qualified Importer Program (VQIP)
application portal for fiscal year (FY) 2022.
3. FDA Adds Clarifying Descriptions to the Food Traceability List; Publishes FAQ on Food
Traceability Proposed Rule. The U.S. Food and Drug Administration has made two
updates to its materials for stakeholders regarding the proposed rule, “Requirements for
Additional Traceability Records for Certain Foods” (Food Traceability Proposed Rule).

6. This Month’s Focus:
For Food & Beverage Manufacturers
Preventing a FSVP 483

7. FSMA FRIDAYS
The Foreign Supplier Verification Programs (FSVP) Rule
● FDA FSMA rule on Foreign Supplier Verification Programs (FSVP) for
Importers of Food for Humans and Animals
○ Preventing food hazards
○ Address safety of human and animal food throughout the supply chain
○ Provides the FDA with new tools to ensure safe food for U.S. consumers
regardless of where the food is produced!
● Intention of the FSVP Rule:
● Imported foods meet same safety standards as U.S.-produced food
● Importers are responsible in ensuring the safety of imported food by
verifying that its suppliers are doing the right thing to meet requirements

8. FSMA FRIDAYS
Key Principles of an FSVP
● Shared responsibility of importer and foreign supplier in safety of imported food
● FSVP requirements are risk-based
○ What type of food is it?
○ What type of hazards are there?
○ How has the supplier performed?
● There is flexibility for meeting requirements

9. FSMA FRIDAYS
The FSVP
All records and documentation that
demonstrate compliance with
applicable FSVP requirements for a
particular imported food product
and/or foreign supplier

10. FSMA FRIDAYS
Someone must take responsibility
of FSVP responsibilities on the U.S.
side of things
Who’s Impacted?
Who is an IMPORTER?
“the U.S. owner or consignee of an article
of food that is being offered for import
into the United States”
21 CFR Part 1, Subpart L, 1.500 Definitions
OR designate an agent or a
representative to carry out FSVP
responsibilities
if no “U.S. owner or consignee”

11. FSMA FRIDAYS
FSVP “Qualified Individual”
“a person who has the education,
training, or experience (or a
combination of these) necessary to
perform an activity required under the
FSVP regulation, and can read and
understand the language of any
records that the person must review in
performing this activity”

12. FSMA FRIDAYS
USDA Regulated Foods
such as certain meat,
poultry, and egg products
Returned U.S. Food
Exports
Recognition of
equivalency
Exempted foods include...
Do the FSVP requirements apply to me?
Most animal and human foods will require an FSVP (unless exempted)
● Low-acid canned foods are not exempt from FSVP
OR personal use only
Foods under FDA HACCP Certain Alcoholic Beverages

13. FSMA FRIDAYS
1. Conduct a hazard analysis of the food (hazard ID & risk evaluation)
2. Evaluate the foreign supplier’s food safety performance and risk posed by
the food
3. Based on #2, approve the foreign supplier
4. Establish written procedures to ensure the food is imported only from
approved foreign suppliers.
5. Determine and apply appropriate verification activities (assess results).
6. Implement corrective action(s), if needed.
7. Re-evaluate foreign supplier (@ least every 3 years)
8. Identify the FSVP importer at entry.
9. Records and documentation!
Standard (Basic) Requirements of an FSVP
FSVP must be completed before any food enters the U.S.

14. FSMA FRIDAYS
Top 5 FDA 483s from
FY2020 Food Facility Inspection
Observations:
1. FSVP Development
2. Sanitation
3. Hazard Analysis
4. Hygienic Design
5. Supply Chain Controls
How Does This Impact You?
instances of
“You Did Not Develop an FSVP”
554

15. FSMA FRIDAYS
Top 5 Citations (Human Food)
✔“You did not develop an FSVP” (485)
✔ Document foreign supplier approval (53)
✔Have a written hazard analysis (47)
✔Document evaluation conducted (44)
✔Establish written procedures to ensure appropriate
verification activities conducted (39)

16. FSMA FRIDAYS
• “You did not maintain or follow an FSVP” (15)
• Did not provide an English translation of a FSVP record written in another language
(13)
• “FSVP did not provide adequate assurance that foreign supplier is producing
[compliant] food [for] public health protection”
• FSVP was not signed/dated
• Did not promptly investigate and document investigation for FSVP adequacy of
foreign supplier
• Did not retain FSVP
• Did not provide FSVP record electronically (to FDA)
• Low-acid canned food: “FSVP did not address all matters that are not controlled by
low acid canned food regulations”
Other FSVP Citations from the FY20 Inspection

17. FSMA FRIDAYS
Looking Ahead at 2021...
• Transition from “educate while we regulate” into enforcement action
• FDA is initiating more “for cause” FSVP inspections
• Re-inspections started in FY2020
FDA Human Food Inspection Citations in FY21 (so far):
• Did not develop an FSVP (28)
• Did not establish written procedures to ensure use of approved foreign
suppliers
• Did not include a known or reasonably foreseeable hazard in hazard analysis
• Did not document evaluation
• Did not have a written hazard analysis

18. How To Avoid a 483...
1. Ensure you have a properly trained (and documented) FSVP QI.
2. Make sure you have an FSVP (if you don’t already have one) for each article of
food you import from each suppliers’ location (oftentimes there is more than one
facility location)
3. If the supplier verification documentation is about to expire (such as a GFSI audit
you are dependent upon), ensure you re-evaluate, and date the FSVP
appropriately.
4. Foreign Supplier Approval: Detail how you do it and what documents are
acceptable (i.e. SOP).
5. DO BASIC HOMEWORK:
a. Has the supplier been in any recall? Are they on any Import Alerts? Did they receive an
483, or a warning letter? Did they have a poor audit?
b. If the answer is “yes”, did they appropriately perform a corrective action?
c. If not, what is your proper corrective action?
6. Did the QI sign and date the FSVP?
7. Is the Hazard Analysis complete? Refer to Appendix 1: Potential Hazards for
Foods and Processes
8. Records: Are they English? Did you retain them for two years after you
discontinued using the Foriegn Supplier/food article or FSVP expired? 18

19. Q & A
FSMA FRIDAY

20. ✔ FSMA Friday Session Recordings & Content Library
✔ TAG Newsletter
✔ Global Food Safety Consultants
AchesonGroup.com
✔ FSMA Friday LinkedIn Group
✔ Q&A, Articles & Updates … Join FSMA FRIDAYS!
Resources & Future Events
FSMA FRIDAYS
April 30, 2021: Is a Return to Normalcy in Sight? What to Know About
Virus Variants, New Vaccine Efficacies, Availability, and a Roundup of
Ways Manufacturing Has Changed Since COVID-19
Ben Miller, PhD, MPH, Senior Director of Regulatory and Scientific Affairs