21 CFR 117.80 - Processes and Controls

What it says

All operations in the receiving, inspecting, transporting, segregating, preparing, processing, packaging and storing of food must be conducted in accordance with adequate sanitation principles, with raw materials and ingredients inspected and handled to protect against contamination, manufacturing operations performed under conditions and controls that minimize the potential for growth of microorganisms and contamination, and measures taken to prevent allergen cross-contact.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• These are the day-to-day controls over how food and ingredients are handled, including storage conditions and segregation.
• Allergen cross-contact prevention includes scheduling, dedicated equipment, cleaning and clear identification of allergen-containing materials.
• Rework and returned product need to be handled in a way that does not introduce a hazard or an undeclared allergen.

What FDA inspectors look for

• Whether raw materials are inspected and stored appropriately.
• Whether allergens are segregated and cross-contact controls are used.
• Whether time and temperature conditions are controlled where microbial growth is a concern.

Related regulations