FDA 483 Citations Under 21 CFR 117.130 and 117.135: Hazard Analysis and Preventive Controls

FDA's preventive controls rule for human food, 21 CFR Part 117 Subpart C, is where a facility's food safety plan is judged. In fiscal year 2025, FDA investigators cited it often on system-generated Form FDA 483s:

• "Your hazard analysis did not identify a hazard that required a preventive control," 117.130(a)(1), 194 times, plus a second version cited 38 times

• "Your written sanitation [preventive control] [monitoring] [corrective action] [verification] procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control," 117.135(c)(3), 86 times

• "You did not implement your process [preventive control] [monitoring] [corrective action] [verification] procedures," 117.135(a)(1), 67 times

• "You did not implement your sanitation [preventive control] [monitoring] [corrective action] [verification] procedures," 117.135(a)(1), 67 times

• "Your written process [preventive control] [monitoring] [corrective action] [verification] procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control," 117.135(c)(1), 62 times

The most cited one, a hazard analysis that missed a hazard, is serious because everything else in the plan depends on it. A hazard that is never identified is never controlled.

What the citations mean

Common examples investigators describe include:

• No hazard identified for environmental pathogens such as Listeria in ready-to-eat food exposed to the environment

• Undeclared allergens not identified as a hazard, or allergen controls missing for shared equipment

• Pathogens not identified for raw ingredients without a kill step

• Process controls, such as cooking or acidification, with no scientific basis for critical limits

• Monitoring records showing deviations with no corrective action

• Verification activities, such as calibration, record review or environmental monitoring, written into the plan but not done

What Part 117 Subpart C requires

117.126, Food safety plan. A facility must prepare, or have prepared, and implement a written food safety plan. It must be prepared, or its preparation overseen, by one or more preventive controls qualified individuals (PCQIs). It must contain the written hazard analysis, preventive controls, supply-chain program, recall plan, and procedures for monitoring, corrective actions and verification.

117.130, Hazard analysis. The facility must conduct a hazard analysis to identify and evaluate, based on experience, illness data, scientific reports and other information, known or reasonably foreseeable hazards for each type of food manufactured, processed, packed or held, to determine whether there are any hazards requiring a preventive control. Hazard identification must consider biological hazards (including microbiological), chemical hazards (including radiological hazards, substances such as pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives and food allergens) and physical hazards. The evaluation must consider the severity of illness or injury and the probability that the hazard will occur in the absence of preventive controls, and include environmental pathogens whenever a ready-to-eat food is exposed to the environment before packaging and the packaged food does not receive a lethal treatment.

117.135, Preventive controls. The facility must identify and implement preventive controls to provide assurances that hazards requiring a preventive control will be significantly minimized or prevented. Preventive controls include, as appropriate, process controls, food allergen controls, sanitation controls, supply-chain controls, a recall plan and other controls.

Management components. Preventive controls are subject to monitoring (117.145), corrective actions and corrections (117.150) and verification (117.155), including validation of process controls (117.160) and verification of implementation and effectiveness (117.165). The plan must be reanalyzed at least once every three years, and whenever certain changes occur (117.170).

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 whether to take further action.

Evaluate product made under the plan

If a hazard was missed or a control was not implemented, evaluate food produced during that period. Consider testing, holding product and, where food may be adulterated, whether a recall is needed. Document the decision.

Reanalyze the hazard analysis

Have a PCQI redo the hazard analysis for each product or product group, using current scientific information and the facility's own history. Document why each hazard does or does not require a preventive control.

Correct the preventive controls

For each hazard requiring control, write controls with scientifically supported parameters, monitoring procedures, corrective action procedures and verification activities. Validate process controls where required.

Show implementation

Provide records showing the controls are now operating: monitoring logs, corrective action records, calibration records and verification reviews. Investigators often cite firms whose plan is correct on paper but not followed.

Train and verify

Train the PCQI, line staff who monitor controls and supervisors who review records. Schedule a reanalysis review and internal verification after the changes have been in place.

What a compliant food safety plan contains

• Product and process descriptions, and flow diagrams

• Written hazard analysis covering biological, chemical, physical and allergen hazards

• Process, allergen, sanitation and supply-chain preventive controls as needed

• Monitoring procedures and records

• Corrective action procedures

• Verification, validation and record review

• Environmental monitoring and product testing where appropriate

• Recall plan

• Reanalysis schedule and triggers

• PCQI identification and signatures

Common mistakes in food safety plan responses

• Updating the hazard analysis without changing what happens on the floor

• Citing published guidance for critical limits without showing it applies to your process

• Treating sanitation as a GMP only, even when environmental pathogens require a sanitation preventive control

• Keeping monitoring records but never reviewing them as verification

• Skipping the reanalysis when products, ingredients or equipment change

Example: how one response section might read

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

Observation 2: Your hazard analysis did not identify a hazard that required a preventive control. Specifically, the hazard analysis for ready-to-eat salads did not identify environmental pathogens.

Response:

• Product assessment: Finished product testing and a review of distribution were performed for product made since the last reanalysis, with results attached.

• Reanalysis: The PCQI reanalyzed the hazard analysis for all ready-to-eat products on a stated date. Listeria monocytogenes from the environment is now identified as a hazard requiring a preventive control.

• Preventive controls: A sanitation preventive control with written procedures, an environmental monitoring program with defined zones, frequencies and corrective actions, and verification activities was implemented on a stated date.

• Root cause: The original plan relied on a generic hazard list and did not apply the requirement for environmental pathogens in exposed ready-to-eat food.

• Training: Sanitation crews, QA technicians and supervisors were trained.

• Verification: Environmental monitoring results will be reviewed weekly and summarized in FDA updates.

Frequently asked questions

Who must prepare the food safety plan?

A preventive controls qualified individual (PCQI) must prepare the plan or oversee its preparation, along with the hazard analysis, validation, record review and reanalysis.

Does every hazard need a preventive control?

No. Only hazards that, based on the hazard analysis, a knowledgeable person would establish controls for. The analysis must document why each hazard does or does not require one.

How often must the plan be reanalyzed?

At least once every three years, and whenever there is a significant change that creates a new hazard or increases a hazard, new information about potential hazards, an unanticipated food safety problem, or a preventive control that proves ineffective.

How A.P. Lyon documents help

A.P. Lyon's FSMA Food Safety Plan and Preventive Controls Procedure, Hazard Analysis Procedure and Preliminary Steps for Hazard Analysis Procedure cover the structure of a Part 117 food safety plan. The Food Safety Plan and HACCP Workbook provides worksheets for hazard analysis and preventive controls, and the Validation of Control Measures Procedure supports process control validation. All are part of the full food safety management system.

Documents are editable Word and Excel files. A food safety plan must be prepared or overseen by your PCQI and based on your own products and processes. A.P. Lyon does not prepare food safety plans or provide food safety consulting.

Next steps

• Evaluate product made while the gap existed

• Have your PCQI reanalyze hazards and correct each preventive control

• Show implementation with current monitoring, corrective action and verification records

• 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.

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