FDA 483 Citations for Personnel Practices Under 21 CFR 117.10

22 hours ago

5 min read

"You did not take a reasonable measure or precaution related to personnel practices." FDA investigators cited 21 CFR 117.10 with that wording 223 times on system-generated Form FDA 483s in fiscal year 2025. It was one of the most cited current good manufacturing practice observations for human food.

People are one of the main ways pathogens and foreign material get into food. Investigators watch the line: whether workers wash their hands when they should, change gloves, keep jewelry and phones out of production, and whether anyone with signs of illness is working with exposed food.

What the citation means

Examples written after "Specifically" usually describe:

Employees not washing hands before starting work, after breaks, or after touching floors, trash or their faces
Gloved hands touching unsanitized surfaces and then food
Jewelry, watches or phones worn in production areas
No hair or beard restraints, or restraints worn incorrectly
Outer garments not suitable, not clean, or worn outside and back into production
Eating, drinking, chewing gum or using tobacco in processing areas
Personal belongings stored in production or storage areas
Employees with open wounds or illness symptoms working with exposed food
No program for employees to report illness

What 21 CFR 117.10 requires

The management of the establishment must take reasonable measures and precautions to ensure the following.

Disease control (117.10(a)). Any person who, by medical examination, the person's acknowledgement or supervisory observation, is shown to have, or appears to have, an illness, open lesion including boils, sores or infected wounds, or any other abnormal source of microbial contamination by which there is a reasonable possibility of food, food-contact surfaces or food-packaging materials becoming contaminated, must be excluded from any operations which may be expected to result in such contamination until the condition is corrected, unless conditions such as open lesions are adequately covered. Personnel must be instructed to report such health conditions to their supervisors.

Cleanliness (117.10(b)). All persons working in direct contact with food, food-contact surfaces and food-packaging materials must conform to hygienic practices while on duty, to the extent necessary to protect against allergen cross-contact and contamination of food. Methods include:

Wearing outer garments suitable to the operation
Maintaining adequate personal cleanliness
Washing hands thoroughly, and sanitizing if necessary, in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated
Removing all unsecured jewelry and other objects that might fall into food, equipment or containers, and removing hand jewelry that cannot be adequately sanitized during periods in which food is manipulated by hand
Maintaining gloves, if used in food handling, in an intact, clean and sanitary condition
Wearing, where appropriate, in an effective manner, hair nets, headbands, caps, beard covers or other effective hair restraints
Storing clothing or other personal belongings in areas other than where food is exposed or where equipment or utensils are washed
Confining eating food, chewing gum, drinking beverages or using tobacco to areas other than where food may be exposed or where equipment or utensils are washed
Taking any other necessary precautions to protect against allergen cross-contact and against contamination of food, food-contact surfaces or food-packaging materials

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 the practices seen

Retrain the employees involved, correct the conditions immediately and evaluate any food that may have been contaminated. Document what was done with dates and photos.

Write clear hygiene rules

Write a personnel hygiene and employee health procedure that turns 117.10 into rules people can follow: when to wash hands, glove rules, jewelry and phone rules, garments and hair restraints, where to eat and store belongings, and how to enter production.

Set up illness reporting and exclusion

Define the symptoms and conditions employees must report, such as vomiting, diarrhea, jaundice, sore throat with fever and infected wounds, who decides on exclusion, and when employees may return. Make reporting easy and free of penalty.

Make compliance easy

Place hand-washing stations where they are needed, stock them, and post signs. Provide lockers, break areas and suitable garments.

Train and verify

Train every employee, contractor and visitor before entering production, in a language they understand. Supervisors should check hygiene practices on every shift and record what they find.

What a compliant personnel hygiene program contains

Hand washing and sanitizing rules
Glove use
Jewelry, phones and personal items
Outer garments and hair restraints
Eating, drinking and tobacco areas
Illness reporting, exclusion and return to work
Wound covering
Visitor and contractor rules
Training and supervisor checks
Records

Common mistakes in personnel practice responses

Retraining once without changing supervision
Writing rules that hand-washing stations or locker space cannot support
Having no illness reporting process
Forgetting visitors, maintenance staff and contractors
Promising training without dates or records

Example: how one response section might read

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

Observation 1: You did not take reasonable measures related to personnel practices. Specifically, two employees returned from break and handled ready-to-eat sandwiches without washing their hands.

Response:

Correction: Production was stopped, and sandwiches made during the observed period were discarded on the same day.
Corrective action: A personnel hygiene and employee health procedure was issued on a stated date. A hand-washing station was added at the entrance to the assembly room, and entry requires passing it.
Training: All 46 production employees were trained in English and Spanish on stated dates, with sign-in records.
Verification: Supervisors check hand washing at each break return and record findings on a daily hygiene checklist. Quality reviews the checklists weekly.

Frequently asked questions

Does 117.10 apply to every employee?

The cleanliness requirements apply to all persons working in direct contact with food, food-contact surfaces and food-packaging materials. Disease control applies to anyone whose condition could contaminate food.

Are gloves required?

No. Gloves are not required, but if they are used, they must be kept intact, clean and sanitary. Gloves do not replace hand washing.

Can a worker with a cut keep working?

Only if the lesion is adequately covered so it cannot contaminate food, food-contact surfaces or packaging, for example with a bandage and glove.

How A.P. Lyon documents help

A.P. Lyon's Personnel Hygiene and Employee Health Procedure covers hand washing, garments, jewelry, illness reporting and exclusion. It works with the Training, Competence and Awareness Procedure and the Visitor and Contractor Control Procedure. All 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. Staff must be trained and the rules followed. A.P. Lyon does not provide food safety consulting or training courses.

Next steps

Correct the practices seen and evaluate affected food
Write hygiene and illness rules people can follow
Train everyone who enters production
Respond in writing within 15 business days with dates for each action

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