FSMA Compliance Checklist for FDA Inspections

FSMA Compliance Checklist for FDA Inspections

| Quality Management | Food Safety | Product Lifecycle Management
Posted By: Jovan Hadžić

FSMA Compliance Checklist for FDA Inspections

Food manufacturers looking to do business in the United States must implement a safety program that complies with FSMA regulations. Failure to comply with FSMA regulations can result in repercussions such as fines, product recalls, lawsuits, or worse, including plant shutdown. 

Trace One’s Trace One Devex PLM system automates quality management as a shared initiative by integrating quality processes directly into ongoing product development procedures.

Key Takeaways for FSMA Compliance for FDA Inspections

  • If you have to register with the FDA, FSMA likely applies to you
  • Violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) can result in fines of up to $500,000, imprisonment, costly recalls, and could endanger consumers
  • Trace One Regulatory Compliance makes it easy to identify and research regulations in global markets

What is FSMA compliance?

The FSMA (Food Safety Monitoring Act), signed into U.S. law in 2011, focuses on preventing serious adverse health consequences by establishing a proactive and risk-based approach in food safety. The FSMA is mandated by the FDA, which consists of 7 major rules for food companies to follow in order to stay compliant:

Produce Safety (PS)

There’s a federal standard for growing, harvesting, packing, and holding of fresh produce. It’s the farm’s responsibility to protect crops from contamination by establishing systems for water quality testing and raw manure application, examining grazing areas, and monitoring employee health and hygiene training, and more.

Preventive Controls Human Food (PCHF)

Food facilities must implement a food safety plan that includes hazard analysis and risk-based preventive controls to minimize hazards.

Preventive Controls Animal Food (PCAF)

Facilities producing food for animals must demonstrate current good manufacturing practices (CGMP), hazard analysis, and risk-based preventive controls.

Foreign Supplier Verification Programs (FSVP)

FSVP establishes rules for importers to perform certain risk-based activities verifying food imported into the U.S has been produced in compliance with FDA regulatory requirements. Importers must perform evaluations while approving suppliers, evaluating supplier’s performance and determining risks and potential hazards associated with food supplies.

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Sanitary Transportation (ST)

Food shippers, receivers, loaders, and carriers that transport food in the U.S. must take appropriate measures in ensuring food safety. This helps protect food from farm to table by maintaining proper temperature controls and preventing contamination during transportation.

Intentional Adulteration (IA)

To prevent intentional adulteration and possible harm to public health, all food facilities are required to develop and implement a food defense plan that covers the assessment of food vulnerabilities, identification of mitigation strategies for vulnerabilities, and determination of monitoring procedures to ensure the effectiveness of mitigation strategies.

Accreditation of third-party auditors/certification bodies

Allows food safety audits to be conducted by accredited third-parties for foreign facilities and the food they produce. Two types of audits are performed: consultative and regulatory, which is a Voluntary action

FDA Inspections are a real concern

According to the FDA, all high-risk domestic facilities must be inspected every three years.

The FSMA created six new kinds of criminal violations under the FD&C Act and has triggered a seventh. Criminal penalties for violations include significant fines, upwards of $250,000 and imprisonment. Fines are doubled for organizations.

FSMA compliance protects consumers and companies, ensuring that U.S. food suppliers focus on preventing contamination rather than responding to it after the fact. The law applies to human food as well as to food for animals, including pets.

How to Make Sure You’re FSMA Compliant 


Prepare a Food Safety Plan

Proper document efforts to ensure the safety of food during manufacturing, processing, packing, and holding. This includes the following primary documents:

  • Hazard analysis
  • Preventive controls
  • Oversight and management of preventive controls
  • Supply chain program
  • Recall plan

 Train Your People

Place trained individuals in charge of your facility’s food safety plan. Create roles and assign responsibility across each stage of the safety plan, including implementation, verification, validation, and correction. 

Identify FSMA Hazards

Identify and assess potential hazards that may arise from the food facility or food itself, including: 

Unintentional or natural hazards like:
  • Biological hazards
  • Chemical hazards
  • Physical hazards
Hazards that may be intentionally introduced, including by acts of terrorism.

Monitor Compliance

Effectiveness and outcomes are a direct result of diligence. Continuous monitoring and visibility establishes consistency in procedures and introduces traceability, making it easier to identify safety issues.

Who Should Use This FSMA Compliance Checklist?

FSMA rules only apply to foods regulated by the FDA. Granted, this is a significant chunk of the U.S. food supply, about 78%. The other 22% is regulated by other agencies, such as the United States Department of Agriculture (USDA), which oversees meat, poultry, and many dairy products. So, if you manufacture meat, poultry or dairy products regulated by the USDA or another agency, then the FSMA does not apply to you.

Commercial farms, packing operations, and food processing facilities are all covered by FSMA. Basically, if you are registered with the FDA as a food manufacturing facility, then you likely need to comply with the FSMA. There are some exemptions, not everyone who grows or processes products overseen by the FDA is automatically affected by the FSMA, so check the FSMA to see if it applies to you.

Companies with a Hazard Analysis and Critical Control Points (HACCP) plan in place are also affected by FSMA and your HACCP plan will need to be updated and enhanced in order to be fully compliant.

FSMA Compliance Checklist from Trace One

Hazard Analysis and Risk-Based Preventive Controls:

  • Preventive Controls Qualified Individual
  • Contents of a Food Safety Plan
  • Hazard Analysis
  • Preventive Controls for Hazards
  • When Preventive Controls are not Required
  • Recall Plan
  • Monitoring
  • Corrective Actions
  • Verification
  • Validation
  • Reanalysis
  • Records Required

Current Good Manufacturing Practices:

  • Qualified Individual
  • Personnel
  • Plant and grounds
  • Sanitary operations
  • Sanitary facilities and controls
  • Equipment and utensils
  • Processes and controls
  • Warehousing and distribution
  • Holding and distribution of human food by-products for use as animal food
  • Defect action levels

Technology & Software Solutions for Monitoring FSMA Compliance

Software solutions such as Trace One’s Trace One Regulatory Compliance accelerate and simplify compliance efforts. To see and minimize compliance risk in product portfolios, regulatory experts at food manufacturers have to navigate an incredible amount of product data, requirements from numerous regulatory bodies and ever-changing global legislation.

Doing manual compliance assessments across multiple global markets, product lines, and regulatory environments isn’t just time-consuming--it’s often inefficient.

With the Trace One Regulatory Compliance, users can access one web-based structured regulatory database to manage ongoing compliance checks, monitor changing food laws, and ensure products remain compliant and competitive in every market. The Trace One Regulatory Compliance is an easy-to-adopt subscription-based tool with no hardware. It is accessible from everywhere.

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The Trace One Difference

Managing food, beverage, and cosmetics product quality standards across product lines is a collaborative process that requires diligence and transparency within all product development, regulatory, and vendor processes. Trace One has the tools and knowhow to help you automate and dramatically streamline manufacturing processes—including FSMA compliance. Schedule a demo with us today to learn more.