April 7, 2022

The U.S. Food and Drug Administration (FDA) has issued dozens of warning letters to date in 2022, also announcing resumed inspections after pausing them amid the Omicron surge. Furthermore, a review of recently posted FDA warning letters highlights a strict approach to enforcement, especially for repeat violations. The emerging implications for the food industry are becoming abundantly clear – regulatory scrutiny is on the horizon. Unfortunately, the potential exists to reveal costly, high-risk food safety compliance gaps that can result in warning letters.

This article looks at some of the top issues appearing in recent FDA warning letters. Additionally, it provides advice for avoiding food safety compliance issues with an enterprise quality management system (QMS).

Food Safety Compliance Issue 1: CGMP Violations

Current Good Manufacturing Practices (CGMP) violations were one of the top problems identified in the most recent crop of FDA warning letters. Specific problems included:

  • Persistent presence of pathogens such as Salmonella and Listeria
  • Sanitation problems including pest exclusion and employee hygiene practices
  • Equipment issues such as leaking machines, dripping pipes, and contaminated forklift tires

In one case, the warning letter reveals an employee picking food up off the floor and placing it back into a production staging area.

QMS takeaway: Food manufacturers everywhere must stay vigilant on CGMP practices. Key QMS functions to leverage here include employee training management, remote audits, and verified corrective action. These processes work together to ensure people are following quality and safety protocols and that any problems are effectively captured and resolved.

Food Safety Compliance Issue 2: Lack of or Inadequate Response

Several recent warning letters reveal critical mistakes when it comes to responding to Form 483 observation letters or other regulatory notices. Common issues include not responding to a Form 483 observation letter, as well as not fully addressing identified violations.

QMS takeaway: Manufacturers only have 15 days to respond to warning letters, a relatively tight timeline when relying on paper records. An automated quality management system can help streamline regulatory communications and avoid these issues by making it simple to:

  • Capture, track, update, and submit documentation electronically to make the process faster
  • Document observations and quickly assign action items needed to respond to FDA findings
  • Compile information digitally on corrective actions, including supporting materials such as photos, purchasing records, and communications with third parties
  • Set alerts and reminders so you don’t miss regulatory and corporate deadlines

Food Safety Compliance Issue 3: Environmental Pathogens

Pathogens including Listeria and Salmonella appear in multiple recent FDA warning letters. In some cases, the agency cites plants for not evaluating these hazards. Most striking, however, are examples of ongoing problems where corrective actions have proven ineffective, and incidents continue.

In one example, the FDA performed whole genome sequencing on environmental samples from a plant, comparing genetic data among samples from multiple inspection dates. The agency made a confirmation that the company’s corrective action processes are ineffective. Specifically, effectiveness checks were off-target, and no root cause was thoroughly investigated.

QMS takeaway: Effectively eradicating environmental pathogens requires comprehensive processes for:

  • Root cause analysis
  • Developing preventive controls that address the true root cause of problems
  • Documenting testing protocols and results, and tracking them over time to detect emerging risks
  • Risk-based corrective action
  • Change management to ensure that changes to manufacturing processes don’t introduce unforeseen risks
  • Communicating all the information in a digital format with a cross-functional team of remote and on-premise subject matter experts.

Food Safety Compliance Issue 4: Undeclared Allergens and Other Ingredients    

Several FDA warning letters to date in 2022 have noted undeclared allergens and ingredients. Problems include issues such as:

  • Not disclosing component ingredients or sub-ingredients, for example, listing graham cracker as a single ingredient in ice cream
  • Not evaluating allergen cross-contact and whether it requires a preventive control
  • Incorrect product labels—a key consumer issue —including where labels did not disclose when products were produced on shared equipment

QMS takeaway: Undisclosed allergens are a huge risk to consumers, and can result in expansive recalls. Implementing preventive controls via proactive risk management is essential to prevent cross contamination. Finally, document control solutions should be tightly integrated with labeling procedures and ingredient lists to ensure identification and proper disclosure of allergens and component ingredients.

Food Safety Compliance Issue 5: Sanitation Failures

Unfortunately, sanitation is a continually recurring issue in food inspections. Falling under hazard analysis and risk-based preventive controls, sanitation problems are no less common in recent warning letters. The failures ran the gamut from bird droppings observed in production areas to returning food to the production line after falling on the floor.

What is the real issue when it comes to sanitation problems? A few things could be going on:

  • The culture of the organization has allowed for it to happen, where people see a lack of accountability around following procedures.
  • Staffing shortages mean the rest of the staff is spread thin and more likely to make mistakes.
  • New employees are still learning and not clear on required sanitation procedures and risk mitigations.
  • Old equipment isn’t engineered correctly to meet today’s sanitation requirements.

 QMS takeaway: Connecting your document control system and employee training management ensures any new or updated documents are reflected in training requirements. Adding in mobile audits to gauge training effectiveness provides accountability. Furthermore, implementing a closed-loop corrective actions ensure any problems identified are resolved.

In addition, consider adding video recordings as objective evidence for use in root cause analysis investigations. This strategy is only practical with an electronic QMS, and can’t be done with paper processes or amongst shared servers.

 Food Safety Compliance Issue 6: Documentation Issues

Documentation gaps are common among manufacturers receiving FDA warning letters, specifically in areas like:

  • Supporting documentation for corrective actions and effectiveness checks
  • Documentation of supplier audits
  • Training records
  • Records related to environmental monitoring and testing

QMS takeaway: Having documentation in order is critical should you find yourself under scrutiny by the FDA. Document management software is essential to keeping records in order, allowing you to pull them together quickly by making them centrally accessible location. This also makes it possible to see where gaps might exist.

Furthermore, document management maintains all documents, revisions, and complete document history. This allows you to demonstrate ongoing improvement and show the gaps you have closed.


With FDA inspections resuming, food manufacturers can expect greater scrutiny and an increased likelihood of regulators discovering food safety violations in their plants.

It’s far better to do the work of conducting internal audits and controlling problems within a QMS, rather than waiting for the FDA to call you out. Leveraging solutions such as corrective action, document control, audits, and employee training enable companies to improve food safety and protect profits and reputation.

Related Reading:

FDA Traceability: What the Food and Beverage Industry Needs to Know

About the Author

Kevin Tom is Director of Product Management for the Life Science and Manufacturing industries at AssurX. Kevin is responsible for driving customer value and product growth through innovation and strategic product vision. Kevin brings over 10 years of information technology experience in several functions, including ERP consulting, system implementations, and QA/project management for web-based configuration platforms.  Additionally, he has 10 years of progressive product management experience in both the chemical and nylon plastic industries, and 10 years of supply chain leadership experience in both the generic drug and medical device markets.