Life involves three types of decisions: must do, could do and should do. Among these, the “must” decisions are the easiest because external forces often make them for us. These are actions that must be completed due to obligations or rules. For example, paying taxes in the United States is a “must” decision. Regardless of personal feelings, people comply to avoid penalties or jail time. It’s straightforward because the consequences of inaction are clear and immediate. Once completed, most individuals move on with their year, repeating the process annually without much thought. 

In contrast, “could” decisions are far more complex and overwhelming. These represent the plethora of options available to us, offering opportunities to choose any path forward. While the abundance of options is a privilege, it can also be paralyzing. This is illustrated by a metaphor of customers in an ice cream shop, faced with endless flavor combinations. Excitement quickly turns to overwhelm as they struggle to choose, often defaulting to the simplest or first option. This behavior demonstrates how, when faced with too many possibilities, people often settle for what feels easiest rather than what might be the best choice. 

The same dynamic applies to decision-making in other areas of life, including food safety. Many professionals in the field fall back on the simplest programs or policies they encounter early in their careers. Over time, these established practices persist, not because they are optimal, but because they are functional and easy to maintain. Whether someone is new to food safety or has years of expertise, the challenge lies in navigating a vast array of choices without the certainty of a “right” answer. Food safety, like medicine, is a practice developed through experience, mentorship and learning from past events. 

Next are “should” decisions, which are the most complex and nuanced. These decisions sit in a gray area between “must” and “could,” requiring a balance of personal ethics, professional responsibility, and context. Unlike “must” decisions with clear rules, or “could” decisions driven by open-ended possibilities, “should” decisions often involve ambiguity. For food safety professionals, these decisions dominate their work. They constantly navigate scenarios where the right answer isn’t clear until after the fact, such as deciding whether a missing plastic knob likely fell into a production vat or assessing the safety of products after a refrigeration failure. 

The difficulty of “should” decisions lies in their reliance on judgment rather than rules. While it’s the food safety professional’s role to ensure food is safe for consumption, they must also ensure products are still viable to sell. Overly strict decisions might eliminate all risks but could leave no product to distribute. Conversely, leniency might preserve inventory but increase potential dangers to public health. This constant balancing act highlights the complexity of the “should” category, requiring professionals to weigh risks, outcomes and ethical considerations in real-time. 

In the end, life’s decisions are rarely black and white. The “must” decisions are the simplest because they are dictated by external forces. The “could” decisions represent boundless possibilities but often lead to overwhelm. And the “should” decisions, which merge elements of the first two, are where most of life—and especially professional roles like food safety—exists. These decisions require the courage to operate in uncertainty, relying on experience, mentorship, and a commitment to doing what seems best in a world full of gray areas. 

Western Growers Science team recognizes that the challenge for the Produce food safety professional is difficult and increasing with research leading to enhanced understanding of our environments and potential risks. Navigating the “should” decisions in day-to-day food safety decision-making can be overwhelming, especially within fresh produce where the complexity of the supply chain and production environment is high, and the direct ability to manage all variables is low. Western Growers is here to help, and we are building a library of tools and information to make “should” decision-making easier. Through our programs, we are supporting the industry by building resources to optimize learnings on risk management, increasing produce food safety expertise through mentorship, collaboration and educational materials and designing transformational systems like GreenLink® for enhanced food safety data utilization.  

Interested in cultivating the future of produce food safety? Join us.  

Updated: 1/21/2025

1 ) What part of the FDA conducts food facility inspections?

The enactment of the Food Safety Modernization Act (FSMA) expanded the FDA’s inspection authority significantly. Initially, FDA inspections of farms occurred mainly during foodborne illness investigations or findings of potential food adulteration. Now, inspections also include routine inspections and occur more frequently sometimes without prior notice. These inspections are conducted by the Office of Human Food Inspectorate, part of the Office of Inspections and Investigations (OII). As of October 1, 2024, the OII replaced the Office of Regulatory Affairs (ORA).

State and local agencies also partner with the FDA to conduct inspections under cooperative agreements. These agencies might follow different protocols, but they generally align with FDA standards.

2 ) How many inspectors should you expect to see during an inspection?  Is it typical for inspectors to come from different offices (state, federal)?  What do you do when the inspectors arrive? What information are you entitled to? 

Number of inspectors: The number of inspectors may vary depending on the scope of the inspection.  Inspections can also be opportunities for training new inspectors, inspectors to learn new types of facilities and/or inspectors to calibrate across different offices.

State and federal collaboration: Inspections may involve personnel from both FDA and state agencies working under cooperative agreements.

What to do when inspectors arrive:

• Inspectors must present a Notice of Inspection (Form FDA-482 or FDA-482(c)) to your designated company contact before proceeding with the inspection.
  • This form includes the inspection date, the name and title of the firm representative, the firm’s name and location, and the authority granted by the Food, Drug, and Cosmetic Act (FD&C Act).
  • It must be signed by the inspector and display the name and address of their District Office.
• If state or local officials conduct the inspection and do not provide this form, document their credentials and any information about their inspection authority.
• Keep a copy of the Notice of Inspection for your records.

3 ) What are the different types of inspections? VIA vs OIA?

The FDA and its state partners conduct three main types of inspections:

1. Surveillance Inspections: Routine, proactive inspections to ensure compliance with FDA regulations.
2. Compliance Follow-Up Inspections: Conducted to verify corrective actions taken after previous observations.
3. For-Cause Inspections: Triggered by specific events, such as a foodborne illness outbreak or consumer complaint.

Inspection classifications:
Inspections are classified into three categories based on findings:

1. No Action Indicated (NAI): No objectionable conditions or practices were observed.
2. Voluntary Action Indicated (VAI): Objectionable conditions or practices were found, but no regulatory action is recommended.
3. Official Action Indicated (OAI): Regulatory or administrative actions are recommended based on significant violations.

The final classification (OAI) considers observations made during the inspection, the facility’s response to Form FDA-483, and corrective actions taken.

4 ) Can we explain the difference between an observation (483) versus a violation?

An FDA Form 483 is issued at the end of an inspection when an investigator observes conditions that may violate the FD&C Act or related regulations. It lists observations in order of risk significance and typically includes:

• A citation of the relevant law, regulation or act.
• Specific details about the observed conditions.

Key distinctions:

• Observation: Potential issues noted by inspectors. A 483 does not constitute a violation or final regulatory action.
• Violation: Determined after further evaluation of the 483 and other evidence, which may result in regulatory or administrative action.

You should review 483 observations carefully and respond promptly with proposed corrective actions.

It’s important to realize that not all 483s are the same! Jennifer McEntire recently posted a story regarding the mischaracterization of the 483, which in plain words offers a clear explanation of what 483 forms are or aren’t.

5 ) What are common observations during inspections?  FDA publishes a summary of inspection data, where can I find it?

Common observations during inspections include issues related to:

• Sanitation and hygiene practices.
• Documentation and record-keeping.
• Equipment maintenance and calibration.

The FDA publishes a summary of inspection data, including final classifications, in its FDA Inspection Database (FDA Dashboards – Inspections). The agency maintains an inspection database that includes final inspection classifications (updated weekly). Once an inspection has been classified and it is considered closed it is added to this database.

In 2024, approximately 74% of inspections resulted in “No Action Indicated” (NAI), while less than 2% resulted in “Official Action Indicated” (OAI).More statistics can be obtained from the FDA’s data dashboard to provide more context about inspection findings.

Table 1. 2024 Food/Cosmetic inspection based on findings.

6 ) How do I prepare for when the inspector arrives at my facility?

Preparation is key. Companies should establish an Inspection Team and written procedures to manage inspections effectively. Key responsibilities include:

• Escort Protocol: Ensure inspectors are escorted at all times while on the premises.
• Point of Contact: Designate a Company Contact to respond to inspector questions and requests.
• Document Management: Have clear policies for disclosing records, trade secrets and confidential information.
• Use of Equipment: Be aware of policies regarding inspectors’ use of recording devices, photography and sampling procedures.

Companies should also ensure that inspectors comply with internal health and safety rules. Resources like the Western Growers FDA Inspections Manual (FDA Inspections Manual ) provide detailed guidance on planning, managing inspections and post-inspection follow-up.

7 ) What to do when a company believes the FDA has misunderstood an aspect during an inspection?

When a company identifies a potential misunderstanding during an FDA inspection, it’s important to address the issue promptly and professionally. Following these steps can help ensure the situation is resolved effectively:

• Provide a Detailed Response: Explain why you believe the observation stems from a misunderstanding. Include background information, contextual explanations and evidence to support your position. This helps FDA officials, who may not be familiar with your operations, understand your perspective.
• Maintain Professionalism: Contesting an FDA observation is acceptable, but it must be done respectfully and constructively. Ensure your response focuses on clarifying the misunderstanding rather than appearing confrontational.
• Engage with the FDA District Office: The district office oversees the inspection process and the work of field investigators. If communication with the on-site investigator does not resolve an issue, contacting the district office can help escalate and address confusion regarding inspection findings or misunderstandings.
• Document All Communications: Keep detailed records of all interactions with the FDA. Proper documentation is invaluable if further discussions or escalations are necessary.

By following these steps, companies can address misunderstandings during FDA inspections through clear communication, constructive dialogue and appropriate channels.

The U.S. Food and Drug Administration (FDA) has announced a new strategy to prevent contamination of fresh and frozen berries with enteric viruses such as Hepatitis A Virus (HAV) and human norovirus (NoV). This initiative is part of FDA’s efforts to enhance food safety and reduce foodborne illnesses.

The FDA’s prevention strategy addresses factors that may contribute to contamination, such as inadequate hygienic practices among field workers, cross-contamination during processing and gaps in food safety systems. The strategy also emphasizes the importance of scientific research to detect and understand enteric viruses, including their persistence in agricultural environments and processing facilities.

Reducing foodborne illness requires a coordinated effort throughout the supply chain. The FDA’s strategy underscores the shared responsibility of regulators, industry and other stakeholders in ensuring the safety of fresh and frozen berries.

For more information, visit the FDA’s website here.

A summary of the FDA’s new prevention strategy is available here.

Stop Foodborne Illness (STOP), a national public health nonprofit dedicated to preventing foodborne illnesses, has announced that Sandra Eskin, a renowned food safety advocate and former USDA Deputy Under Secretary for Food Safety, will take on the role of CEO starting Feb. 24, 2025.

Eskin, who has played a pivotal role in advancing food safety reform throughout her career, succeeds Mitzi Baum, who expanded STOP’s national profile during her six-year tenure. Under Eskin’s leadership, STOP aims to build on this momentum and strengthen its efforts to protect consumers and prevent foodborne illnesses.

Click here to read the full press release.