What Are FDA Warning Letters?

The Food and Drug Administration regulates the food safety of most of the United States’ food supply, with the exception of meat and poultry products under the jurisdiction of the USDA. As such, the FDA has the authority to enter and inspect food manufacturing facilities that process food that will be consumed by those in the United States. The FDA expects food facilities that prepare, pack, or hold food to do so under sanitary conditions. The FDA also expects food manufacturers to meet the standards detailed in the hazard analysis and risk-based preventive controls regulation, which was a major part of the Food Safety Modernization act (FSMA).

Food manufacturers must follow FSMA standards in order to avoid receiving a warning letter from the FDA.

If the FDA identifies significant concerns during an inspection (whether domestically or internationally), they may issue a warning letter citing the violations. The food company must then take action to achieve compliance.

FDA warning letters are for Food, Beverage, and Dietary Supplement sectors.  The FDA sends these warning letters to manufactures if they find that they have significantly violated FDA regulations.  FDA warning letters are posted publicly on the FDA website so they are visible to consumers, customers, and the general public—even if the violation is fixed.  The warning letter will include various other information including what the violation is, when it occurred and when it needs to be addressed by the manufacturer.

 Many food manufacturers are worried about receiving a warning letter from the FDA and rightfully so; it is a permanent public record of an FDA violation. 

Ensure FDA compliance so that your facility does not receive an FDA warning letter because it is a permanent public record.