The FDA Inspection Crisis is a Call to Invest in Food Safety Tech

Key takeaways: 

• The FDA’s inspection capacity is collapsing: There were 19% fewer inspections in 2023 than in 2017, with 26% of high-risk facilities going uninspected beyond required timeframes, creating widespread regulatory gaps.
• Manufacturers have an 18-24 month window to build internal quality systems before oversight becomes even more inconsistent, as FDA shifts responsibility to underfunded state agencies.
• Three technology investments offer immediate ROI — real-time environmental monitoring, employee compliance tracking, and predictive maintenance.

Imagine that your facility hasn’t been inspected by the FDA in over three years. You’re operating under the assumption that “no news is good news.” Then, without warning, investigators show up for a surprise inspection and discover what they classify as significant violations — conditions that could pose a hazard to public health.

For 861 food facilities between 2017 and 2023, this nightmare became reality. And, unfortunately, 91% of these facilities didn’t receive a timely follow-up inspection within six months, leaving them in regulatory limbo while potentially distributing unsafe products.

This is the new reality of food safety oversight — where federal inspection gaps are widening, state agencies are overwhelmed, and failing to invest in internal quality systems exposes manufacturers to high operational risks.

The FDA’s inspection system is breaking down

A new report from the Department of Health and Human Services Office of Inspector General (OIG) shows that the FDA inspected 19% fewer facilities in 2023 compared to 2017, even as the number of food facilities requiring inspection increased by over 5,000.

• High-risk facilities: 26% weren’t inspected within the required 3-year timeframe — meaning that more than a quarter of the facilities with the greatest threat of foodborne illness went years without oversight.
• Non-high-risk facilities: 34% missed their required 5-year inspection cycle, leaving these facilities operating without federal verification of safety standards.
• Other facilities: The FDA attempted to inspect over 8,700 seasonal or temporarily closed facilities, but 88% never received a follow-up physical inspection.

On top of this, the FDA is reportedly planning to eliminate most routine food safety inspections and shift responsibility to state agencies, many of which lack the infrastructure and funding to handle the workload.

Innovation can close gaps in quality assurance

When inspections did occur, investigators found some significant violations, including a South Carolina doughnut manufacturer cited for unsanitary practices (employees not washing hands, placing soiled gloves on food lines, and allowing flies on dough) and a food facility in Florida that tested positive for Listeria monocytogenes during four consecutive inspections but failed to take corrective action to eliminate the pathogen.

These examples represent systemic gaps that technology-forward manufacturers are addressing through internal quality assurance systems. Smart manufacturers aren’t waiting for the regulatory system to fix itself — they’re taking necessary steps to ensure that, inspection or not, the safety and quality of their products is never at risk. 

To meet current inspection mandates, the FDA would need to inspect 7,000 high-risk facilities and 11,000 non-high-risk facilities annually. They’re currently achieving only 58% and 56% of those targets, respectively. That gap represents thousands of facilities operating with minimal oversight — creating massive market opportunities for manufacturers who can demonstrate superior internal quality controls.

Companies that start building comprehensive internal quality systems now will gain:

• Competitive differentiation when customers demand proof of quality standards
• Reduced liability exposure from contamination events
• Operational cost savings from preventing violations and recalls
• Market positioning as quality leaders during industry consolidation

Three technology investments that deliver fast ROI

Based on the violation patterns revealed in the OIG report, three technology categories offer immediate returns, according to industry data:

1. Real-time environmental monitoring systems

Problem addressed: Listeria and other contamination issues plague facilities.

Potential ROI: Companies lose an average of $10 million per recall in direct costs alone. Automated environmental monitoring programs can help food manufacturers achieve significant improvements in production performance and waste reduction.

2. Employee compliance tracking technology

Problem addressed: Poor employee practices lead to significant violations.

Potential ROI: Food safety technology requires half the amount of time and staff to complete most food safety tasks, with businesses saving 10 hours weekly on routine tasks.

3. Predictive maintenance and equipment monitoring

Problem addressed: Equipment-related contamination and insanitary conditions risks food safety.

Potential ROI: Food manufacturers could lose 1 to 3% of production time due to equipment cleaning and maintenance cycles or equipment failures — predictive maintenance systems prevent this.

Action steps

The FDA’s plan to shift inspections to states is moving forward, but state agencies are already seeing their budgets cut. State “rapid response” teams lost 60% of funding, produce inspection budgets dropped 40%, and manufactured food programs infrastructure was cut 50%.

This creates an 18-24 month window where oversight will be minimal and inconsistent. The manufacturers who thrive in this new environment will be those who act decisively.

Immediate (next 30 days):

• Conduct gap analysis of current quality systems against OIG violation patterns
• Calculate ROI for internal monitoring technology investments
• Identify vendor partnerships for rapid implementation

Short-term (90 days):

• Implement employee compliance tracking systems
• Install environmental monitoring in high-risk areas
• Establish predictive maintenance protocols

Strategic (6-12 months):

• Build comprehensive quality management platform
• Develop supplier verification systems
• Create documentation systems for regulatory readiness

The question isn’t whether you can afford to invest in internal quality systems. With FDA’s inspection capacity declining and regulatory uncertainty growing, the question is whether you can afford not to.

Food manufacturers who act quickly can turn this regulatory chaos into a competitive advantage.