How to Avoid the Top FDA Regulatory Violations of 2020

Posted by Zosi Team

In an unprecedented year for the food industry, regulatory compliance is top of mind as we all work to keep our employees, consumers, and products safe.

These are the top violation groups for food manufacturing facilities in 2020, as reported by the FDA’s Office of Regulatory Affairs. Understanding these violations can help your organization safeguard against making these mistakes in 2021.

Top FDA Regulatory Violations

Develop an FSVP

Believe it or not, ORA reports the failure to develop a Foreign Supplier Verification Program (FSVP) as the most frequent FDA regulatory violation. What is an FSVP? According to the FDA, importers covered under the FSMA Rule for Foreign Suppliers must have a foreign supplier verification in place. Under this rule, importers must verify that their foreign supplies follow food safety standards equivalent to the standards established by the FDA. Companies that do not have an importer in the U.S. must appoint an FSVP agent responsible for these verification activities.

Activities that should be conducted under foreign supplier verification include the following:

Hazard analyses (section 1.504)
Evaluation of food and the foreign supplier (section 1.505 and section 1.506).
Taking corrective and preventive actions wherever necessary (section 1.508).
Record maintenance (section 1.510).

Hazard Analysis / Identification

As you probably know by now, Hazard Analysis Critical Control Points (HACCP) procedures are the backbone of every food safety system. This violation group saw facilities fail to identify a known or reasonably foreseeable hazard that required preventive control.

Hazard identification is conducted through thorough hazard analysis. This critical practice identifies the biological, chemical, or physical hazards that could occur at each step in your manufacturing process.

You must take care to identify all the potential hazards that could be associated with the raw materials, processes, and finished products to assure you identify all necessary Critical Control Points (CCPS) or Preventive Controls as applicable, or procedures at which you can apply control to prevent, eliminate, or reduce a hazard to an acceptable level.

Typical examples of CCPs and Preventive Controls include cooking processes, chilling, and metal detection.

To learn more about HACCP principles, HACCP plans, and CCPs, click here.

Pest Control

The third-largest group of FDA regulatory violations centers around pest control. In some cases, a failure to exclude pests from the food plant was cited. In others, a failure to use pesticides under precautions and restriction was noted. Both cases present an enormous problem in preventing the contamination of food supplies.

Sanitation Monitoring

This violation group cites facilities for not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with current Good Manufacturing Practices (cGMPs). This includes:

safety of water that comes into contact with food or food contact surfaces (including water used to manufacture ice)
the condition and cleanliness of food contact surfaces
prevention of cross-contamination from unsanitary objects
maintenance of handwashing, hand sanitizing, and toilet facilities
protection of food, food packaging material, and food contact surfaces from adulteration
proper labeling, storage, and use of toxic chemicals
control of employee health conditions

For more information on effective sanitation practices and how to avoid this violation umbrella, click here.


Want more insight into the citations issued against various regulations covered under 21 CFR 117 Preventive Controls for Human Food? Download our latest Zosi Live session. This 60-minute virtual roundtable expands on the top violation groups above and more, tackling everything from sanitation and Food Safety Plans, to allergens and training. Enrich our conversation with feedback from your own audit experiences and learn as your food industry peers weigh in using their own!

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