FDA 483 Citations for Food Allergen Preventive Controls Under 21 CFR 117.135

22 hours ago

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Undeclared allergens are one of the leading causes of FDA food recalls. In fiscal year 2025, FDA investigators recorded these observations about allergen preventive controls on system-generated Form FDA 483s:

Did not implement your food allergen preventive controls, 117.135(a)(1), 55 times
Written food allergen control procedures not appropriate to ensure protection from allergen cross-contact or correct labeling, 117.135(c)(2), 36 times

That is more than 90 citations. They usually involve one of two failures: an allergen got into a product where it did not belong, or the label did not declare an allergen that was in the product.

What the citations mean

Examples written after "Specifically" usually describe:

Products with and without an allergen made on the same line with no validated cleaning between them
No production scheduling to run allergen-free products first
Shared utensils, scoops or containers between allergen and non-allergen products
Allergen ingredients stored above or beside other ingredients without protection
Rework containing an allergen added to products that do not declare it
No label check at packaging, or labels from one product applied to another
Ingredient changes from a supplier, such as a new spice blend containing wheat or sesame, not reviewed for allergens
Allergen controls written in the food safety plan but not monitored or recorded

What 21 CFR 117.135 requires

Preventive controls (117.135(a)). You must identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented, and that the food will not be adulterated or misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act, which covers allergen labeling. Preventive controls must be written.

Food allergen controls (117.135(c)(2)). Food allergen controls must include procedures, practices and processes to control food allergens. They must include those employed for:

Ensuring protection of food from allergen cross-contact, including during storage, handling and use
Labeling the finished food, including ensuring that the finished food is not misbranded under section 403(w)

Management components (117.140). Allergen controls are subject to monitoring (117.145), corrective actions and corrections (117.150) and verification (117.155 and 117.165), as appropriate to the nature of the control and its role in the food safety system. Records must document the monitoring, corrective actions and verification.

Major food allergens. Under the Food Allergen Labeling and Consumer Protection Act, as amended by the FASTER Act, there are nine major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame. Sesame became a major food allergen on January 1, 2023.

Part 117 good manufacturing practices also require precautions against allergen cross-contact throughout the plant, under 117.80 and 117.93.

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. If product in distribution may contain an undeclared allergen, contact FDA and consider a recall right away, because this is a common cause of Class I recalls.

Assess product in distribution

For any product that may contain an undeclared allergen, review production and cleaning records, test where useful, and decide whether a recall or correction is needed.

Map allergens in the facility

List every allergen in every ingredient, including spices, flavorings and processing aids. Map where each allergen is received, stored, used and packaged.

Control cross-contact

Production scheduling, allergen-free first
Validated cleaning between allergen changeovers, with visual inspection and, where appropriate, allergen-specific swab testing
Dedicated or color-coded utensils and containers
Segregated, labeled storage
Rework controls that match allergen profiles

Control labeling

Label review against the formula and ingredient specifications before printing
Label verification at the start of each run, at changeovers and when new label stock is loaded
Removal of obsolete labels
Review of supplier ingredient changes for new allergens

Monitor, correct and verify

Record allergen changeover cleaning and label checks every time. Define what happens when a check fails. Have the PCQI review records and verify that cleaning is effective.

What compliant allergen preventive controls contain

Allergen map and ingredient allergen list
Cross-contact controls: scheduling, cleaning, segregation, utensils, rework
Cleaning validation and verification
Label review and on-line label verification
Supplier change review
Monitoring records
Corrections and corrective actions
Verification and records review
Training

Common mistakes in allergen control responses

Retraining without adding monitoring or records
Cleaning between changeovers without showing it removes the allergen
Checking labels only at the start of the shift
Missing allergens in compound ingredients such as spice blends and flavorings
Forgetting sesame or other newer label requirements

Example: how one response section might read

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

Observation 10: You did not implement your food allergen preventive controls. Specifically, the line was not cleaned between the peanut butter cookies and the oatmeal cookies, and no changeover record exists.

Response:

Product action: Oatmeal cookies made after the peanut run were held, tested for peanut protein and destroyed after a positive result. No affected product had shipped.
Corrective action: An allergen changeover procedure now requires a full clean, visual inspection and a peanut protein swab test, recorded and signed off by the supervisor before the next product starts.
Scheduling: Peanut products now run last on the line each day.
Labeling: Label verification is recorded at start-up, at each changeover and when new label rolls are loaded.
Verification: The PCQI reviews changeover and label records weekly, and cleaning effectiveness was validated on a stated date.

Frequently asked questions

Are "may contain" statements a substitute for allergen controls?

No. Precautionary allergen statements are voluntary and not a substitute for good manufacturing practices and preventive controls. FDA expects firms to control cross-contact.

Is sesame a major allergen?

Yes. Sesame became the ninth major food allergen on January 1, 2023, under the FASTER Act.

Do allergen controls always need validation?

Part 117 does not require validation of allergen controls. Verifying that changeover cleaning removes allergens, for example with swab tests, is still good practice and shows the control works.

How A.P. Lyon documents help

A.P. Lyon's Allergen Management Procedure covers allergen mapping, cross-contact controls, changeover cleaning and verification. The Product Labeling and Label Review Procedure covers label review and on-line checks, and the FSMA Food Safety Plan and Preventive Controls Procedure links allergen controls to the food safety plan. All 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. A PCQI must oversee your preventive controls. A.P. Lyon does not provide food safety consulting.

Next steps

Assess product that may contain undeclared allergens
Map allergens and control cross-contact
Verify labels at every run and changeover
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.