By: Keeba Smith

When proper food safety principles and procedures are not followed, the risk of foodborne illness and other dangerous consequences can occur.  Restaurants and other places that serve food to the public are held to a higher and stricter standard when it comes to food safety.  Health inspectors from local regulatory authorities visit various establishment and grade each facility according to food regulations and standards.  Health inspectors have the power to enter premises; inspect and investigate; take measurements, samples and photographs; require an area or machine to be left undisturbed; seize, render harmless or destroy dangerous items; and obtain information and take statements.  They also have the power to issue improvement and prohibition notices, and can bring prosecutions against any persons contravening a relevant statutory provision.

Inspection violations can result in warning letters, placement on import alert, suspension of facility registration, and other enforcement actions.

Below are the Food and Drug Administration’s (FDA) 2017 top 5 most commonly cited food safety violations:

1. Pest Exclusion/Screening: (303 violations) Pest control citations are the most frequent citations given.  The FDA issues violations to food companies for not taking effective measures to exclude pests from processing areas and failing to prevent the contamination of food by pests.

The agency requires food manufacturers to have a detailed pest management policy and program that is documented and conducted under the supervision of a licensed pest control contractor.

2. Sanitation Monitoring: (211 violations) If given a citation, it means the sanitation conditions and practices are not monitored frequently enough to satisfy Current Good Manufacturing Practices (CGMPs).  The agency noted in the past, common errors involved water contact with or food contacts surfaces; cross-contamination from insanitary objects; poor hand washing, hand sanitizing, and toilet facilities; improper labeling, storage and use of toxic chemicals and more.

Under Food Safety Modernization Act (FSMA) provisions, all registered facilities must comply with CGMPs and have preventative controls in place.  These controls include training, audits, documentation and validation.

3. Plant Cleanliness: (203 violations) All manufacturing plants must be constructed in a manner that allows all floors, walls and ceiling to be adequately cleaned.  A citation means the facility either failed to maintain cleanliness of the premises or cannot do so due to its construction.  A written procedure and documentation for cleaning practices should be available as well.

4. HACCP Plan Implementation: (176 violations)  In 2017, seafood or juice processors failed to implement certain procedures in its HACCP plan, such as critical control points of food hazards or verifying the adequacy of the plan’s hazard control.  The FDA issues citations to food manufactures that do not fully implement or commit to their Hazard Analysis and Critical Control Points (HACCP) plans.  If processes, such as monitoring, record keeping or verification, were not performed, a violation was cited.  While organizations can use existing food safety programs as part of their preventive controls, HACCP plans need to be consistently updates, reviewed and implemented.

5. Reasonable Precautions: Precautions must be taken to prevent production procedures from contaminating food, including not monitoring time and temperature of processed foods or not monitoring operations, such as freezing or heat processing.  Violation of this procedure will warrant a citation.

FDA 2017

Each year, the FDA issues out hundreds of citations to food companies in the form of warning letters (Form 483s), and each subsequent year publishes the data on the FDA website.  The list of violations occurred during routine food facility visits made from October 2016 to September 2017.  The top five cited violations for the Fiscal Year of 2017 are the same as the Fiscal Year 2016.  The list is compiled for food manufacturing operations to keep these in mind and pay particularly close attention to before a FDA inspection.

To protect the public health, FDA monitors domestic firms and the food that they produce.  FDA also has multiple initiatives for monitoring imported products and foreign firms exporting to the United States.  The FDA protects consumers from unsafe food.

The FDA believes the Fiscal Year 2018 list of violations may look quite different than the previous years.  The FDA is now in the process of implementing the Food Safety Modernization Act.  Before most companies weren’t subject to food safety rules that were implemented in September.  They predict more FSMA violations in 2018.


The FDA Food Safety Modernization Act is based on preventing problems before they happen, rather than solely responding to outbreaks of foodborne illness.  They will use data and other information to help identify hazards that need to be addressed and minimized.

The Food Safety Modernization Act requires the FDA to perform a certain number of domestic and foreign inspections per year.  The FDA has to conduct more than 19,200 foreign inspections per year which is up from the previous 2,400 required inspections per year.  Importers never had to be inspected before, but food safety regulations have changed that.  Importers have until March 19 to comply with the new food safety regulations.  Importers must have a Foreign Supplier Verification Program for their suppliers.  The FDA predict most violations will come from importers failing to comply with the program plan.



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