FDA food storage warehouse regulations control cleanliness and sanitation in food warehouses. An extensive list of FDA requirements and regular inspections keep food warehouses on their toes and ensure that facility design, food handling, storage practices, temperature control, and more are upheld to the highest standards.

The food and beverage industry affects virtually everyone on the planet—it encompasses the production, processing, distribution, and sale of food and beverages that are essential for human survival. Proper storage and handling techniques, regulated by the FDA, are crucial, ensuring that the food you buy is fresh and safe to eat.

FDA Approved Food Storage Warehouse Regulations

About the Food and Drug Administration (FDA)

The U.S. Food and Drug Administration (FDA) is a regulatory agency committed to promoting and protecting public health through food storage warehouse standards and more. They regulate a broad scope of sectors, including:

  • Food and beverages
  • Drugs
  • Biologics
  • Medical Devices
  • Electronic products that omit radiation
  • Cosmetics
  • Veterinary products
  • Tobacco Products
U.S. Food and Drug Administration logo

The FDA regulates everything related to the food and beverage industry, from science and research to retail food protection and more. 

FDA Food Grade Warehouse Regulations

Food warehousing is an intermediate process in the food supply chain that occurs after harvest/production but before retail to consumers. Foods like raw ingredients, produce, frozen and refrigerated foods, raw meats, etc., are often stored temporarily before being shipped to restaurants or grocery stores. Warehouses must keep food fresh and isolated from germs, corrosion, or bacteria during this time. 

Here are some of the most common FDA food storage warehouse regulations as defined in the Current Good Manufacturing Practice (CGMP) found in Title 21 of the Code of Federal Regulations (CFR) Part 117:

FDA Warehouse Registration

  • FDA food warehouse registration: Warehouses must register with the FDA to obtain an FDA Establishment Identifier (FEI) number. Facilities must renew their FDA warehouse certifications annually.
  • Registration fees: FDA-certified warehouses are typically required to pay an annual FDA registration fee.
  • Pre-Approval Inspection (PAI): The FDA may conduct a PAI to ensure compliance with the CGMP and other regulatory requirements.

General Requirements

  • Sanitation standards: FDA sanitation standards call for frequent cleaning and sanitizing of all food-contact surfaces, including utensils, equipment, and food-grade storage systems.
  • Pest control measures: Proper waste storage and pest control substances are required to exclude pests from food storage facilities.
  • Record-keeping and documentation: Facilities must maintain Standard Operating Procedures (SOPs) for all critical processes, including receiving, storage, handling, and shipping. These, along with records of cleaning schedules, training logs, and pest control measures, verify compliance during FDA inspections.

Facility Standards

  • Design and construction requirements: The FDA requires that building structure/design, layout, floors, walls, ceilings, lighting, ventilation, water supply, and plumbing be designed in such a way that prevents contamination. Regulations for design and construction are also outlined in the CGMP.
  • Maintenance of the facility: Facility maintenance standards require general upkeep of the physical structure, regular cleaning and sanitizing, regular inspections, and preventative maintenance.
  • Equipment standards: Food and beverage equipment must be designed and installed to allow easy cleanability and maintenance. Regular sanitation, inspections, preventative maintenance, and monitoring systems are required to ensure equipment is in proper working order.
  • Food-grade pallet standards: Although the FDA does not have specific regulations dedicated solely to food-grade pallets, there are general food safety requirements that outline pallet standards. The pallet material must be non-toxic, non-absorbent, food-safe, easy to clean, and durable. Pallets should be wood-treated for pest control and should be regularly inspected for damage.

Operational Standards

  • Employee training and hygiene: Protective clothing, such as gloves, hairnets, shoe covers, or full-body protective suits, must be worn, and employees must maintain personal cleanliness. 
  • Handling and storage practices: Employees must inspect all incoming raw materials, segregate them from finished products, and store them with consistent stock rotation in a FIFO (First In, First Out) system. Temperature and humidity control, ventilation, and clear packaging and labeling are essential, and warehouse managers must uphold proper sanitation standards.
  • Temperature control and monitoring: Food products requiring cold storage in freezers or refrigerators must have adequate monitoring systems to keep the area at the appropriate temperature and prevent spoiling. The FDA recommends non-corrosive storage systems like galvanized or stainless steel pallet racking in cooler and freezer storage areas.

Inspection and Compliance

  • Regular FDA inspections: The FDA’s routine inspections verify compliance and food safety and outline corrective actions for food-grade warehousing if necessary. 
  • Common violations and penalties: Inadequate sanitation, employee hygiene, temperature control failures, cross-contamination, structural deficiencies, equipment malfunctions, incomplete records, and more may lead to warning letters, monetary fines, product seizures, or severe legal penalties.
  • Steps for maintaining compliance: Implementing a comprehensive food safety plan, adhering to the CGMP, maintaining proper storage practices, and keeping accurate records are a few ways to ensure FDA compliance.

Types of Products Requiring FDA-Registered Warehousing

  • Fruits

  • Vegetables

  • Dairy Products

  • Meat, Poultry, and Seafood

  • Canned and Packaged Foods

  • Dry Storage (Grains, Cereals, Etc.)

  • Organic and Natural Foods

  • Allergy-Sensitive Products

  • Frozen Foods

  • Restaurant Storage

10 Benefits of Following FDA Regulations

Although FDA compliance is an involved and often rigorous process, these standards are in place for the safety and protection of you and consumers worldwide. Following the CGMP is crucial. Some often unseen benefits of FDA regulation adherence include:

  1. Consumer Safety
  2. Reduced risk of foodborne illness
  3. Legal and financial protection
  4. Fine avoidance
  5. Operational efficiency
  6. Streamlined warehouse operations
  7. Quality work environment
  8. Reduced waste
  9. Market access
  10. Expanded marketing opportunities

Final Thoughts on FDA Warehouse Regulations

The FDA is a crucial player in the food supply chain, setting the guidelines and standards for food storage and handling. FDA-approved warehouses must undergo regular inspections to prove that they can consistently comply with the extensive sanitation and operational requirements outlined in the CGMP. 

Although demanding, FDA compliance is a warehouse manager’s best friend, keeping facilities out of legal trouble or scandals concerning sanitation or health concerns.

Warehouse operators and food businesses should embrace FDA regulation adherence as an opportunity to grow and improve operations. The FDA establishes training, sanitation, and maintenance suggestions to keep people safe. Compliance improves work environments, employee and customer satisfaction, and the entire food and beverage industry.

Additional Resources

The FDA’s Current Good Manufacturing Practices (CGMP) can be found in Title 21 of the Code of Federal Regulations (FDR) Part 117, and outline most of the FDA regulations required for food warehouses.

Check out the FDA’s Food Overview Section and related resources.

Congress enacted the Food Safety Modernization Act (FSMA) to prevent foodborne illnesses.

Here are some Food Facility Registration Guidelines to get started on your FDA warehouse registration.

Hazard Analysis Critical Control Point (HACCP) is a management system that addresses food safety through analysis and control of various hazards in FDA-governed facilities.

Check out these FDA Food Education and Resources to get your facility and staff up-to-date on current training and more.

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