In my work with food and beverage manufacturers across the country, I continue to see one pattern repeat itself: regulatory violations rarely happen because people don’t care, they happen because systems, documentation, and preventive controls fall out of alignment with real-world daily operations.
In a recent FSMA Friday session, we reviewed several regulatory violations that surfaced over the past years. Though the facilities, products, and processes varied, the underlying issues were strikingly similar, and entirely preventable. In this article, I will explain why these violations occur and, more importantly, what practical steps you can take right now to strengthen compliance and reduce risk inside your own facility.
The Most Common Regulatory Violations & Why They Still Happen
After decades in the field, I’ve learned that regulatory patterns are valuable teachers. The violations we reviewed point to several recurring weaknesses across the industry:
1. Outdated or Incomplete Food Safety Plans & Hazard Analyses
Too often, facilities create a strong plan initially but fail to update it when new ingredients, equipment, formulations, or suppliers are introduced. FSMA requires a living, evolving plan that reflects your current process, not your process from two years ago.
The root cause:
Lack of consistent reanalysis, unclear ownership, or the assumption that “nothing has changed enough to update the plan.”
Lack of consistent reanalysis, unclear ownership, or the assumption that “nothing has changed enough to update the plan.”
2. Poor Documentation or Missing Records
I say this often because it is absolutely true: “If it isn’t documented, it didn’t happen.” Regulators treat missing or incomplete records as non-compliance, regardless of whether the actual activity took place.
The root cause:
Paper-based or fragmented documentation systems, inconsistent training, or staff simply “falling behind” during busy shifts.
Paper-based or fragmented documentation systems, inconsistent training, or staff simply “falling behind” during busy shifts.
3. Inadequate Sanitation & Environmental Monitoring
Sanitation failures remain one of the leading causes of contamination and recalls. Issues range from poorly validated sanitation procedures to inconsistent pre-op inspections and environmental swabbing.
The root cause:
Outdated SOPs, insufficient proof of sanitation efficacy, or lack of corrective action when environmental positives appear.
Outdated SOPs, insufficient proof of sanitation efficacy, or lack of corrective action when environmental positives appear.
4. Allergen Cross-Contact & Labeling Errors
Undeclared allergens continue to dominate recall statistics. Most allergen-related violations stem from weak line-clearance procedures, incorrect labeling, or cross-contact in shared-equipment environments.
The root cause:
Rushed changeovers, inadequate cleaning and verification steps, or inconsistent ingredient control.
Rushed changeovers, inadequate cleaning and verification steps, or inconsistent ingredient control.
5. Weak Supplier Verification Programs
FSMA requires manufacturers to verify that their suppliers are controlling risks appropriately. Yet many facilities still rely on assumptions, outdated documentation, or supplier “reputations.”
The root cause:
Incomplete supplier onboarding, failure to request up-to-date COAs or audits, and lack of a risk-based supply-chain program.
Incomplete supplier onboarding, failure to request up-to-date COAs or audits, and lack of a risk-based supply-chain program.
6. Insufficient Training & Food Safety Culture
Even the best-designed systems fail without properly trained people. Violations often point to inconsistent execution, not because employees don’t want to follow procedures, but because training is infrequent or ineffective.
The root cause:
One-time training events instead of continuous skill building; lack of leadership reinforcement; or cultural norms that prioritize speed over safety.
One-time training events instead of continuous skill building; lack of leadership reinforcement; or cultural norms that prioritize speed over safety.
How to Avoid These Violations: A Practical Roadmap for FSMA Compliance
Every violation we discussed has a clear preventive path. Start by keeping your food safety plan truly active by revisiting hazards regularly (especially after process changes), documenting your preventive controls, and assigning clear ownership so updates never slip through the cracks. Ensure monitoring and corrective-action records are complete and stored securely, and consider moving from paper to digital systems to eliminate gaps while reinforcing with your team why documentation matters.
Sanitation and environmental monitoring must also be robust. Verify your sanitation procedures with appropriate testing, review environmental data for trends rather than isolated results, and conduct documented pre-op inspections (especially if you manufacture ready-to-eat products). Allergen control is another critical area: standardize changeovers, verify allergen cleaning steps, double-check labels before runs, and audit allergen programs frequently to prevent cross-contact and mislabeling.
Your supplier program should be risk-based and continuously updated. Request COAs, audits, and hazard analyses on a regular schedule, and don’t hesitate to verify information independently because you remain responsible for what enters your facility.
Finally, prioritize continuous training. Short, ongoing learning moments and shift huddles make food safety part of everyday culture, encouraging employees to speak up and reinforcing safe behavior. Ultimately, a strong, engaged food safety culture is your most powerful preventive control.
Compliance Is a Journey, Not a Destination
My hope is that by understanding the patterns behind recent regulatory violations, you can take meaningful steps to strengthen your own programs. Whether it’s updating a food safety plan, closing gaps in GMP implementation and documentation, or refreshing training approaches, improvement is always possible, and always worth it.
Food safety is everyone’s responsibility. And together, we can build systems that not only meet regulatory expectations but truly protect public health.
Watch the full webinar replay below:
