FDA 483 Citations for Processes and Controls Under 21 CFR 117.80

22 hours ago

6 min read

FDA investigators cited the processes and controls section of the human food current good manufacturing practice rule often on system-generated Form FDA 483s in fiscal year 2025:

"You did not conduct operations under conditions and controls necessary to minimize the potential for [the growth or survival of microorganisms] [allergen cross-contact] [contamination of food] [deterioration of food]," 117.80(c), 200 times
Operations not conducted in accordance with adequate sanitation principles, or without adequate precautions against allergen cross-contact and contamination, 117.80(a), 34 times
No appropriate quality control operations to ensure food is suitable for human consumption, 117.80(a)(2), 27 times
No effective measures to protect against the inclusion of metal or other extraneous material in food, 117.80(c)(8), 24 times

That is more than 280 citations. Section 117.80 is broad on purpose. It covers how raw materials are handled, how food moves through the plant, how long it sits at unsafe temperatures, and whether anything stops foreign material from reaching the package.

What the citations mean

Examples written after "Specifically" usually describe:

Perishable ingredients or finished food held at room temperature for hours
Cooling of cooked food too slow, with no time and temperature records
Raw and ready-to-eat product sharing equipment, utensils or space
Allergen-containing product run before allergen-free product without cleaning
Condensate, peeling paint or overhead structures dripping onto exposed food
Food or ingredients stored on the floor, open, or in damaged containers
No metal detector, magnet, screen or sieve where metal or extraneous material is likely
Metal detectors never tested, or rejected product not handled
No incoming inspection of raw materials
Rework handled without controls

What 21 CFR 117.80 requires

General (117.80(a)). All operations in the manufacturing, processing, packing and holding of food, including operations directed to receiving, inspecting, transporting and segregating, must be conducted in accordance with adequate sanitation principles. Appropriate quality control operations must be employed to ensure that food is suitable for human consumption and that food-packaging materials are safe and suitable. Overall sanitation of the plant must be under the supervision of one or more competent individuals assigned responsibility for this function. Adequate precautions must be taken to ensure that production procedures do not contribute to allergen cross-contact and to contamination from any source. Chemical, microbial or extraneous-material testing procedures must be used where necessary to identify sanitation failures or possible allergen cross-contact and food contamination. Food that is contaminated to the extent that it is adulterated must be rejected, or treated or processed to eliminate the contamination.

Raw materials and other ingredients (117.80(b)). Raw materials and ingredients must be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into food, and must be stored under conditions that will protect against allergen cross-contact, contamination and deterioration. They must not contain levels of microorganisms that may render the food injurious, or must be pasteurized or otherwise treated. Raw materials susceptible to aflatoxin and other natural toxins must comply with FDA regulations and action levels.

Manufacturing operations (117.80(c)). All food manufacturing, processing, packing and holding must be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, allergen cross-contact, contamination of food and deterioration of food. Among other things, the section requires:

Equipment, utensils and containers maintained in an acceptable condition through appropriate cleaning and sanitizing
Food that can support rapid growth of undesirable microorganisms held at temperatures that will prevent the food from becoming adulterated
Measures such as sterilizing, irradiating, pasteurizing, cooking, freezing, refrigerating, controlling pH or controlling water activity that are adequate to destroy or prevent the growth of undesirable microorganisms
Work-in-process and rework handled in a manner that protects against allergen cross-contact, contamination and growth of undesirable microorganisms
Protection of finished food from allergen cross-contact and contamination by raw materials, other ingredients or refuse
Effective measures to protect against the inclusion of metal or other extraneous material in food (117.80(c)(8))
Proper handling of adulterated food, and of food that has been rejected

Facilities subject to preventive controls under Subpart C may also need process, allergen and sanitation preventive controls for hazards identified in their hazard analysis. Part 117 good manufacturing practices apply whether or not preventive controls are required.

How to respond to the 483

FDA does not set a single deadline for responding to a food 483, but most firms respond in writing within 15 business days, so FDA has the response before it decides on further action.

Correct and assess

Correct each condition seen and evaluate food that may have been affected. Hold, test or destroy product as needed, and record the decision.

Map the process

Walk the product flow from receiving to shipping. For each step, identify where microorganisms can grow, where allergen cross-contact or contamination can happen, and where foreign material can enter.

Put controls in place

Time and temperature limits for holding, cooling and thawing, with monitoring records
Segregation of raw and ready-to-eat product, and of allergen and non-allergen production
Production scheduling and cleaning between allergen changeovers
Metal detection, magnets, screens or sieves where needed, with routine challenge testing and rejected product handling
Incoming inspection of raw materials and packaging
Rework rules
Condensate and overhead control

Assign responsibility

Name the competent person responsible for overall plant sanitation and quality control operations, and define their authority.

Verify

Review monitoring records, trend findings and check controls during internal inspections.

What compliant process controls contain

Process flow and hazards at each step
Time and temperature controls and records
Raw material inspection and storage
Segregation and allergen scheduling
Foreign material controls and testing
Rework and work-in-process handling
Handling of rejected and adulterated food
Named sanitation and quality control responsibility
Monitoring, review and records

Common mistakes in process control responses

Fixing the one product the investigator saw and not others made the same way
Installing a metal detector without challenge testing or reject handling
Setting time and temperature limits without monitoring them
Ignoring condensate and overhead structures
Treating allergen scheduling as a cleaning issue only

Example: how one response section might read

This illustrates structure only; your response must describe your own facts.

Observation 2: You did not conduct operations under conditions and controls necessary to minimize the growth of microorganisms. Specifically, cooked chicken was left at room temperature for more than four hours before slicing.

Response:

Product action: The affected lot was destroyed on the day of the inspection.
Corrective action: A cooling procedure now requires cooked chicken to reach 41°F or below within a defined time, with temperatures recorded at set intervals by the cook. A blast chiller was installed on a stated date.
Training: Kitchen staff were trained on the cooling procedure.
Verification: The quality supervisor reviews cooling logs daily and checks product temperatures weekly.

Frequently asked questions

Do we need a metal detector?

Not always. Section 117.80(c)(8) requires effective measures against metal or extraneous material. Metal detectors, magnets, screens and sieves are examples. Choose based on your process and hazards.

What is a competent individual for sanitation?

Someone with the education, training or experience to supervise overall plant sanitation, assigned that responsibility by management.

Does 117.80 apply if we have a food safety plan?

Yes. Good manufacturing practices in Subpart B apply in addition to any preventive controls in your food safety plan.

How A.P. Lyon documents help

A.P. Lyon's Foreign Material Control Procedure, Allergen Management Procedure, Rework Control Procedure and Receiving and Inspection of Incoming Materials Procedure cover the main controls in 117.80. They are written for ISO 22000, FSSC 22000 and FDA 21 CFR 117, and are also available within the full food safety management system.

Documents are editable Word and Excel files and must be adapted to your facility and products. Limits must come from your own process and product data. A.P. Lyon does not provide food safety consulting.

Next steps

Correct each condition and assess affected food
Map your process and put controls at each step
Assign responsibility for sanitation and quality control
Respond in writing within 15 business days with dates for each action

To build a complete set of procedures at a volume discount, use Build Your QMS.

Not sure where your quality system stands? Take the free QMS gap check: about 20 questions, an instant report of your gaps by clause, and the procedures that close each one.