FDA 483 Citations for Food Safety Training and Qualified Individuals Under 21 CFR 117.4

22 hours ago

5 min read

"You did not [ensure that all individuals who manufacture, process, pack, or hold food are qualified to perform their assigned duties] [have records documenting training in the principles of food hygiene and food safety]." FDA investigators cited 21 CFR 117.4 with that wording 61 times on system-generated Form FDA 483s in fiscal year 2025.

Section 117.4 underpins every other good manufacturing practice. When an investigator sees poor hand washing or a sanitation failure, the next question is often about training: was this person trained, on what, and where is the record? Without records, a firm cannot show that anyone was trained at all.

What the citation means

Examples written after "Specifically" usually describe:

No records of food hygiene or food safety training for production employees
Training given verbally on the first day, with nothing recorded
Training only in a language some employees do not understand
Supervisors with no training in food safety or in supervising hygiene
Temporary or agency workers placed on the line without training
No preventive controls qualified individual (PCQI) for the food safety plan
Training records that list a topic but not the date, content or trainee

What 21 CFR 117.4 requires

Qualified individuals (117.4(a) and (b)). The management of an establishment must ensure that all individuals who manufacture, process, pack or hold food subject to Part 117 are qualified to perform their assigned duties. Each individual engaged in these activities, including temporary and seasonal personnel, or in the supervision of them, must:

Be a qualified individual, meaning a person who has the education, training or experience, or a combination, necessary to manufacture, process, pack or hold clean and safe food as appropriate to their assigned duties
Receive training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as appropriate to the food, the facility and the individual's assigned duties

Supervisors (117.4(c)). Responsibility for ensuring compliance by individuals must be clearly assigned to supervisory personnel who have the education, training or experience, or a combination, necessary to supervise the production of clean and safe food.

Records (117.4(d)). Records that document the required training in the principles of food hygiene and food safety must be established and maintained, and are subject to the recordkeeping requirements of Subpart F.

Preventive controls qualified individual (117.180). Facilities subject to preventive controls must have one or more PCQIs who prepare or oversee the food safety plan, validation of preventive controls, records review and reanalysis. A PCQI must have successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA, or be otherwise qualified through job experience. Records of PCQI training must be kept.

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.

Train and record now

Train everyone who handles food, including temporary staff and supervisors, in food hygiene and food safety appropriate to their jobs. Record the date, trainer, content, trainee and how understanding was checked.

Build a training program

A training matrix listing each job and the training it requires
Initial training before working with food, and refresher training at a set frequency
Training in languages employees understand, with pictures and demonstrations where useful
Job-specific training, such as sanitation, allergen changeover, monitoring of preventive controls and metal detector checks
Supervisor training on how to supervise hygiene and correct problems
A way to check understanding, such as observation or a short quiz

Name and qualify the PCQI

If you are subject to preventive controls, name at least one PCQI, document their training or job experience, and keep the record.

Keep records

Keep training records with other Subpart F records, for at least 2 years.

What a compliant training program contains

Training matrix by job
Food hygiene and food safety basics for everyone
Job-specific training
Supervisor training
Temporary and agency worker training
Language and format suited to the workforce
Effectiveness checks
PCQI qualification records
Training records

Common mistakes in training responses

Holding one training session without changing onboarding
Leaving out temporary and agency workers
Training only in English when employees speak other languages
Recording attendance without content or effectiveness
Forgetting to name and document the PCQI

Example: how one response section might read

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

Observation 7: You did not have records documenting training in the principles of food hygiene and food safety. Specifically, no training records exist for 23 production employees.

Response:

Correction: All 23 employees, plus 6 agency workers, completed food hygiene and food safety training in English and Spanish on stated dates. Records show the content, trainer and an observed hand-washing check for each person.
Corrective action: A training procedure and matrix were issued. New employees and agency workers are trained before starting work, and everyone receives annual refresher training.
Supervisors: Line supervisors completed additional training on supervising hygiene practices.
PCQI: The quality manager's PCQI training certificate is now filed with the food safety plan.
Verification: Human resources will not schedule anyone for production without a completed training record.

Frequently asked questions

Does every employee need training records?

Yes, for individuals who manufacture, process, pack or hold food. Section 117.4(d) requires records documenting the required food hygiene and food safety training.

Do temporary workers need training?

Yes. Section 117.4(b) includes temporary and seasonal personnel.

Must the PCQI be an employee?

No. The PCQI does not have to be an employee, but must perform or oversee the required activities and be qualified by training or experience.

How A.P. Lyon documents help

A.P. Lyon's Training, Competence and Awareness Procedure covers training needs, the training matrix, effectiveness checks and records. It works with the Personnel Hygiene and Employee Health Procedure and the Organization, Roles and Food Safety Team Procedure. 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 workforce. PCQI training must be obtained separately. A.P. Lyon does not provide food safety consulting or training courses.

Next steps

Train and record everyone who handles food
Build a training matrix with onboarding and refreshers
Name and document the PCQI
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.