When the Food Safety Modernization Act (FSMA) became law in 2011, it marked the most sweeping reform of U.S. food safety laws in more than 70 years. Its goal was clear: shift our national approach from reacting to foodborne illness outbreaks to preventing them.

For quality professionals, this change meant more than regulatory updates; it redefined expectations for how food safety is managed, documented, and continuously improved across the supply chain.

Today, QA leaders play a pivotal role in ensuring that their organizations not only comply with FSMA’s complex requirements but also embed food safety into the culture of daily operations.

In this article, we’ll walk through the key elements of FSMA, its foundational rules, and practical strategies for maintaining compliance and readiness.

Why FSMA Was Created

Before FSMA, U.S. food safety regulation was largely reactive, focusing on managing contamination events after they occurred rather than preventing them.

The 2000s brought several high-profile outbreaks E. coli in spinach, Salmonella in peanut butter, and melamine in imported foods that exposed critical weaknesses in oversight. At the same time, the U.S. food supply became increasingly globalized and complex.

Today, roughly 15–20% of all food consumed in the U.S. is imported, making risk management across the supply chain more challenging. Each year, foodborne illnesses still impact nearly 10 million Americans, leading to over 50,000 hospitalizations and almost a thousand deaths.

FSMA was designed to change this landscape by empowering the FDA to focus on prevention through stronger, science-based standards, supply chain accountability, and proactive verification.

The Framework of FSMA: Seven Foundational Rules

FSMA is built around seven core rules finalized between 2015 and 2016, forming the backbone of the modern preventive food safety system:

1. Preventive Controls for Human Food (PCHF)
2. Foreign Supplier Verification Program (FSVP)
3. Sanitary Transportation of Human and Animal Food
4. Preventive Controls for Animal Food
5. Produce Safety Rule
6. Mitigation Strategies to Protect Food Against Intentional Adulteration (Food Defense)
7. Accredited Third-Party Certification

Additional rules have since been finalized, such as the Food Traceability Final Rule (Section 204), Laboratory Accreditation Rule (LAAF), and updates to Agricultural Water standards.

For most food manufacturers and importers, four of these are most critical: PCHF, FSVP, Sanitary Transportation, and Food Traceability.

How FSMA Builds on GMPs

FSMA didn’t replace Current Good Manufacturing Practices (cGMPs)—it expanded upon them. GMPs remain the operational baseline that ensures food is produced safely and under sanitary conditions.

Under 21 CFR Part 117, GMPs require:

• Personnel and hygiene: Training, cleanliness, and illness control
• Facility and equipment design: Construction and maintenance for food safety
• Sanitary operations: Cleaning and sanitizing food-contact surfaces
• Process controls: Procedures to ensure food suitability
• Documentation: Records that verify consistent compliance

FSMA takes this further by requiring facilities to identify hazards and implement preventive controls based on risk. In short, GMPs define how operations are conducted; FSMA defines why and when those operations must be validated through documented risk analysis.

Without GMP compliance, FSMA compliance isn’t possible. A Food Safety Plan built on weak operational foundations won’t withstand FDA scrutiny.

Rule 1: Preventive Controls for Human Food (PCHF)

The PCHF Rule requires registered food facilities to implement a written Food Safety Plan developed and overseen by a Preventive Controls Qualified Individual (PCQI).

That plan must include:

• Hazard Analysis – Identify known or foreseeable hazards.
• Preventive Controls – Establish risk-based strategies to minimize hazards.
• Monitoring and Corrective Actions – Ensure controls are effective and deviations are addressed.
• Verification Activities – Confirm the Food Safety Plan functions as intended.
• Recall Plan – Define procedures for removing unsafe food from the market.

Each covered facility must have a designated PCQI, either an internal leader or a qualified consultant, responsible for developing and maintaining the plan.

The key takeaway: your Food Safety Plan is a living document. It should evolve as your ingredients, processes, and suppliers change.

Rule 2: Foreign Supplier Verification Program (FSVP)

The Foreign Supplier Verification Program (FSVP) is FSMA’s response to the global nature of today’s food supply. It ensures that imported food is as safe as food produced domestically.

U.S. importers must verify that foreign suppliers are producing food that meets U.S. standards by conducting:

• Hazard analyses
• Supplier evaluations based on risk and compliance history
• Verification activities such as audits, testing, or record reviews
• Corrective actions when suppliers fail to meet requirements

Importers must keep documentation such as audit reports, Certificates of Analysis, and verification records for at least two years, ready for FDA inspection.

For QA leaders, FSVP is both a compliance mandate and a strategic layer of protection against supplier risk.

Rule 3: Sanitary Transportation

The Sanitary Transportation Rule ensures food is transported under safe, sanitary conditions to prevent contamination. It applies to shippers, loaders, carriers, and receivers of food transported by motor or rail within the U.S.

Key requirements include:

• Properly designed and maintained vehicles
• Temperature control for perishable foods
• Sanitation procedures to prevent cross-contamination
• Training and documentation for all personnel

Training is critical. Employees involved in loading, unloading, and transporting must understand food safety practices, and training records must be retained for at least one year.

Rule 4: Food Traceability Final Rule (Section 204)

The Food Traceability Final Rule improves traceability for high-risk foods such as leafy greens, nut butters, and seafood. It requires entities to record specific Critical Tracking Events (CTEs) and Key Data Elements (KDEs) to ensure traceability across the supply chain.

Companies must also:

• Maintain a written traceability plan
• Assign and track Traceability Lot Codes (TLCs)
• Provide electronic records within 24 hours of an FDA request

The FDA’s proposed compliance deadline extension to July 20, 2028, offers additional time for businesses to adapt, but preparation should start now.

Regulatory Enforcement and Inspection Readiness

FDA inspections under FSMA are often unannounced. High-risk facilities are typically inspected every three years, while lower-risk facilities are inspected every five.

Inspection readiness depends on:

1. A strong Quality Management System (QMS) with compliant SOPs
2. Accurate documentation that follows the ALCOA+ principles: Attributable, Legible, Contemporaneous, Original, Accurate, and Available

If it’s not documented, it didn’t happen. Lack of documentation remains one of the leading causes of enforcement actions.

The FDA has broad authority, including:

• Issuing Warning Letters and Form 483 Observations
• Ordering Mandatory Recalls
• Suspending facility registrations for severe violations

Practical Strategies for FSMA Compliance

Compliance is a continuous process. These best practices can help QA leaders build resilient programs that withstand inspection scrutiny:

2. Regularly Review Your Food Safety Plan

Review and update the plan quarterly or whenever significant changes occur. Document all updates and involve cross-functional teams in the review process.

3. Conduct Mock Inspections

Simulate FDA inspections to test readiness. Include documentation requests, facility walkthroughs, and staff Q&A. Use results to improve.

4. Leverage FDA Resources

The FDA’s FSMA webpage offers guidance documents, training tools, and templates. Bookmark it and subscribe to updates to stay current.

5. Engage External Experts

Partner with consultants experienced in FSMA to audit your systems, validate preventive controls, and prepare for inspection.

Frequent Areas of Citation

Common FSMA violations often stem from preventable issues:

• Inadequate hygiene practices
• Poor sanitation or pest control
• Lack of documented corrective actions
• Outdated or incomplete Food Safety Plans

Addressing these proactively can prevent costly enforcement actions and reputational harm.

The Bigger Picture: From Compliance to Culture

FSMA represents more than regulatory change—it’s a cultural shift. Prevention, not reaction, must be the guiding principle of every food safety program.

For QA leaders, success under FSMA means building a culture of accountability, readiness, and continuous improvement. When preventive systems and documentation integrity become second nature, compliance follows naturally—and so does consumer trust.

Contact Compliance Architects

At Compliance Architects, we help food manufacturers and importers navigate the complexities of FSMA compliance, from developing Food Safety Plans and conducting risk assessments to preparing for FDA inspections.

If your organization is ready to strengthen its food safety program, contact us to learn how our experts can help.