The FDA citation for lack of a food safety plan included the fact that the facility had not conducted a hazard analysis which would have identified where preventive controls, and their associated elements were needed. Additionally, the manufacturer had no food allergen controls related to potential cross contact in place, nor allergen labeling, despite allergen presence in certain products. Other hazards not identified included Salmonella as a potential biological hazard, so no preventive controls such as those directed at the supply chain were identified for its control, and mycotoxins were not identified as a potential hazard.
The company was also cited for GMP violations due to the use of a household cleaner, that is labeled as NOT for use on food contact surfaces, for cleaning all areas of the facility, including equipment.
With the enactment of the FSMA Preventive Controls rules, it became essential that all human and animal food establishments subject to the rule have a written Food Safety Plan that “consists of the primary documents in a preventive controls food safety system that provides a systematic approach to the identification of food safety hazards that must be controlled to prevent or minimize the likelihood of foodborne illness or injury.” Additionally, FDA’s recent publication of updated draft guidance for the Human Foods PC Rule provided for new approaches to the hazard analysis which you can expect FDA to use in its inspections.
