Several FDA citations were widespread for food businesses in 2022. These citations reflect the priorities and focus of the FDA and provide insight into the areas where tea and food businesses may need to improve in order to comply with the law.
One of the most common citations for these types of businesses in 2022 was for violations of the Current Good Manufacturing Practice (cGMP) regulations. These regulations establish the minimum standards for producing, packaging, and labeling food products and are designed to ensure that food is safe and properly labeled.
"cGMP violations are some of the most common citations that we see," says Tom Colicchio, owner of Crafted Hospitality. "They can be very broad and cover many issues, from inadequate sanitation and food safety controls to improper labeling and packaging."
Common citations range from inadequate sanitation and food safety controls to improper labeling and packaging.
Another common citation for food businesses in 2022 was for violations of the Food Safety Modernization Act (FSMA). This act, which was signed into law in 2011, establishes new requirements for food safety, including preventive controls and hazard analysis.
"FSMA violations can be serious because they can result in a food recall or other regulatory action," says Colicchio. "Food businesses need to be aware of the requirements of the FSMA, and take steps to ensure that they are in compliance."
In addition to these two common citations, several other FDA violations were frequently cited by food businesses in 2022. These included violations of the Food, Drug, and Cosmetic Act (FDCA), which establishes the legal framework for the regulation of food, drugs, and cosmetics in the United States, and violations of the Fair Packaging and Labeling Act (FPLA), which requires that food products be labeled accurately and truthfully.
"FDCA and FPLA violations are also very common," says Colicchio. "Food businesses need to be very careful when labeling and packaging their products to ensure that they comply with the law."
TOP 5 FDA INSPECTION VIOLATIONS
Overall, the FDA citations that were most common for food businesses in 2022 included violations of the cGMP regulations, the FSMA, the FDCA, and the FPLA. These citations reflect the agency's priorities and focus and provide food businesses with a roadmap for compliance—the top 5 violations cited in the FDA Inspection Classification Database in FY 2022.
1. FSVP Violations
Most U.S. food importers must develop Foreign Supplier Verification Programs (FSVPs) for every foreign supplier per product they import. FDA requires FSVPs, so importers provide adequate assurances that their foreign suppliers are producing food that meets FDA’s public health protection standards. Actions an importer must take to provide these assurances may include the following unless an exemption applies:
Determining known or reasonably foreseeable hazards with each food
Evaluating a food’s risk based on the hazard analysis and the supplier’s performance for granting approval
Importing from approved suppliers only
Conducting supplier verification activities
Conducting corrective actions
Having written FSVP procedures
Designating a qualified individual to perform FSVP activities
Identifying themselves as the FSVP Importer at customs entry
2. Pest Control
Pesticide use is permitted, but only under certain precautions and restrictions. Companies must take adequate measures to exclude pests from their food facilities and contaminate food. These safety measures must prevent pesticides from contaminating the food, food-contact surfaces, or materials used to pack food.
3. Sanitary Operations
Food facilities must be maintained in sanitary conditions and undergo regular repairs to prevent food adulteration. Sanitation operations and repairs must extend to the building, fixtures, and any other physical part of the facility. Utensils and equipment must also be cleaned and sanitized to prevent cross-contamination or allergen cross-contact.
4. Manufacturing Controls
Facilities must conduct operations in controlled environments to prevent public health risks. This includes potential microorganism growth, allergen cross-contact, contamination, and food deterioration. These observations can be associated with exposing packaging materials or the food to contamination, lack of allergen controls, subjecting food to temperature abuse, not maintaining adequate moisture levels when handling low moisture foods, not implementing proper process controls for the application of heat treatments or the acidification of food, or not utilizing water of sanitary quality when using ice.
5. Personnel Practices
FDA cites facilities for failing to take measures that ensure personnel is safely handling food. These citations indicate a facility has not applied adequate disease controls or personnel cleanliness measures.
Suppose an individual has a health condition that could contribute to cross-contamination, such as an open lesion or infected wound. In that case, the person must be removed from food handling operations that could cause the food to become contaminated.
Everyone in direct contact with food, food-contact surfaces, and food-packaging materials must observe hygiene practices that prevent allergen cross-contact and contamination, including:
Wearing suitable outer garments
Practicing sufficient personal hygiene
Thorough handwashing
Removal of loose objects that could fall into food, such as jewelry
Maintaining cleanliness of gloves, if used
Restraining or covering hair, when appropriate
Storing personal items in designated areas, away from exposed food or areas where utensils and equipment are washed
Smoking, eating, chewing gum, etc., away from exposed food or areas where utensils and equipment are washed.
Preparation is Key for an FDA Inspection
An FDA facility inspection is thorough, and observations are used to determine if a company should take further action to address public health concerns their procedures may pose. Companies must understand potential violations and make necessary corrections to avoid inspection citations.
HULA CONSULTING IS ON YOUR TEAM
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