When FDA investigators show up at your facility, it may feel like a surprise—but in reality, most inspections are anything but random. They are triggered by specific events, risk factors, or compliance concerns that put your operation on FDA’s radar.
As I explain in In the Midst of a Recall, “FDA rarely knocks without reason. The trigger is usually in your past data—your recalls, complaints, or gaps left unresolved. If you know your weak spots, you already know why they’re coming.”
Understanding these triggers not only helps you prepare—it helps you prevent them. Let’s explore the most common reasons FDA launches an inspection.
Routine Triggers: Scheduled and Risk-Based
- Risk-Based Surveillance: FDA uses a risk-ranking system to prioritize facilities. Higher-risk categories (like ready-to-eat foods, allergen-heavy products, or firms with prior compliance issues) are inspected more often.
- Inspection Cycles: Food facilities are generally inspected every 3–5 years. But if you produce higher-risk products—or have a history of problems—you’ll see inspectors more frequently.
Routine doesn’t mean relaxed. These visits still scrutinize your food safety systems, environmental monitoring, and overall state of control.
Event-Based Triggers: When Something Goes Wrong
Sometimes an inspection is prompted by a specific event in the marketplace:
- Consumer Complaints: A string of consumer illness reports or even repeated quality complaints can draw attention.
- Foodborne Illness Outbreaks: If epidemiology links your product to Salmonella, Listeria, or E. coli, expect investigators at your door.
- Recalls: If you’ve recently issued a voluntary recall, FDA will almost always follow up with an inspection to confirm your corrective actions.
- Adverse Events: Reports of allergic reactions, hospitalizations, or other serious outcomes can trigger immediate action.
As I stress: “Your consumers are your early-warning system. If you ignore their complaints, FDA won’t.”
Regulatory and Compliance Triggers
FDA also acts when there’s reason to believe your compliance program is failing:
- For-Cause Inspections: Initiated by red flags such as mislabeling, undeclared allergens, or contamination issues.
- Follow-Ups on 483s or Warning Letters: If you’ve had open inspectional observations, FDA will return to see if the promised fixes are real.
- Import Concerns: If your supply chain relies on foreign suppliers flagged by FDA, your facility may be targeted under the Foreign Supplier Verification Program (FSVP).
- New Facility or New Product Line: Registering a new site or producing a new category of food can put you on FDA’s list for early inspection.
Emergency Triggers: Protecting Public Health
FDA also has the authority to act when there’s a threat to public health. These inspections may be sudden, aggressive, and highly targeted.
- Section 704(a) FD&C Act Authority: Allows FDA to inspect at any reasonable time, in any reasonable manner, with proper credentials and notice.
- Criminal or Fraud Concerns: In rare cases, falsified records, fraud, or willful violations can bring investigators with enforcement in mind.
In my book: “If you’ve crossed the line from mistakes into misrepresentation, FDA won’t come with a clipboard—they’ll come with a case file.”
What This Means for You
The important lesson? Inspections aren’t random—they’re signals. If you understand the triggers, you can anticipate them and respond from a place of strength rather than panic.
Practical steps to stay prepared:
- Track and trend consumer complaints, and act on them early.
- Close every corrective action from prior inspections—don’t leave gaps.
- Conduct regular mock inspections to surface vulnerabilities.
- Maintain constant readiness in allergen control, sanitation, and documentation.
Or, as my book concludes in In the Midst of a Recall: “The companies that fear inspections are the ones that know they aren’t ready. The companies that welcome inspections are the ones that live in a state of readiness, every day.”
