21 CFR 117.20 and related provisions of the FSMA cGMP subpart establish requirements for the physical plant and grounds of food manufacturing facilities. These are minimum conditions — the physical infrastructure that supports safe food manufacturing.
Grounds Maintenance
Under 21 CFR 117.20(a), the grounds around the facility must be maintained to:
Prevent pooling of water and inadequate drainage that could create contamination pathways
Control weeds, grass, and overgrowth that harbor pests
Eliminate waste and litter that could attract pests
Store equipment, containers, and portable structures in a way that minimizes pest harborage
Facility Construction and Design
Under 21 CFR 117.20(b), the plant itself must be:
Constructed and maintained to allow for adequate cleaning, sanitation, and pest control
Designed to prevent contamination of food from outside sources (pests, environmental contaminants, flooding)
Have adequate floor, wall, and ceiling construction that can be maintained in a sanitary condition (smooth surfaces that can be cleaned)
Well-lit for effective operations — lighting standards in food contact areas, hand washing stations, and inspection areas
Separation of Operations
Food production areas must be physically separated from:
Non-food storage and operations
Waste and refuse areas
Areas that could introduce contamination (raw material receiving vs. finished product areas)
Employee changing rooms and restrooms
Separation may be physical (walls, doors) or procedural (temporal separation, air pressure differentials) depending on the hazard profile.
Drainage and Plumbing
Under 21 CFR 117.37, the facility's plumbing and drainage systems must:
Be adequate in size and properly installed to carry wastewater load
Not create backflow conditions that could contaminate water supplies or food contact surfaces
Have drains in food production areas that drain adequately and do not allow pooling (standing water is a Listeria harborage point)
Provide potable water from an adequate supply for food contact, cleaning, and sanitation
Lighting Requirements
Under 21 CFR 117.20(b)(5), adequate lighting must be provided in:
Areas where food is examined, processed, or stored
Hand-washing areas and restrooms
Any area where employees work in food contact operations
Lighting fixtures in food production areas must be shielded, coated, or otherwise shatter-resistant to prevent glass contamination in the event of breakage.
Ventilation
The facility must have adequate ventilation to:
Minimize odors, vapors, and condensate in food production areas
Control temperature and humidity where relevant to product safety or quality
Prevent cross-contamination from air movement between raw material handling areas and RTE product areas
Facilities producing RTE products with environmental pathogen hazards (Listeria, Salmonella) should particularly consider air handling in their environmental monitoring program.
Pest Control
Under 21 CFR 117.35, the facility must have a pest control program that:
Excludes pests from the facility through physical barriers (sealed doors, pest-proof materials)
Eliminates pest harborage inside and around the facility
Controls pest activity through monitoring (traps, inspections) with documented results
Prohibits use of pesticides in food production areas except in accordance with applicable regulations, and prevents pesticide contamination of food
Pest control is typically a sanitation preventive control for facilities that have identified pests as a significant hazard in their hazard analysis.
Waste Disposal
Under 21 CFR 117.37(f), the facility must have an adequate system for:
Disposing of trash and waste in a timely manner so it does not attract pests or create contamination
Storing waste in designated containers that are clearly marked and kept covered where required
Preventing waste from food production areas from cross-contaminating food or food contact surfaces
Equipment Design and Maintenance
Under 21 CFR 117.40, food contact equipment must be:
Made of non-toxic materials that can be adequately cleaned and sanitized
Designed to prevent accumulation of food particles in hard-to-clean areas
Maintained in a condition that does not contaminate food (no rust, cracks, or deterioration)
Calibrated and maintained to function as intended for food safety purposes
Equipment that cannot be adequately cleaned is a persistent Listeria harborage risk and an environmental monitoring failure point.
How Truli Helps with Plant and Grounds Compliance
Facility inspection readiness review: Truli evaluates plant and grounds maintenance documentation against the cGMP requirements in 21 CFR 117.20 and related sections
Pest control documentation review: Truli assesses pest control program records — trap placement maps, monitoring logs, corrective action documentation — for completeness
Environmental monitoring program support: Truli helps identify high-risk harborage areas (drains, cracks, equipment joints) that should be included in environmental monitoring sampling plans
Related Regulations
21 CFR Part 117 — FSMA Preventive Controls — Full FSMA rule overview
21 CFR 117 Food Safety Plan — Food safety plan requirements
21 CFR 117 Personnel Hygiene — Personnel hygiene requirements
21 CFR Part 111 — Supplement cGMP — Parallel facility requirements for dietary supplement manufacturers
Frequently Asked Questions
Do we need a licensed pest control operator, or can we manage pest control internally?
21 CFR 117.35 does not require a licensed pest control operator — internal pest control programs are permissible. However, for food manufacturing facilities, professional pest control services are standard industry practice and provide documentation that FDA expects to see. Internal programs must be equally rigorous and documented.
We're renting an industrial space. Who is responsible for plant construction compliance?
The registered food facility operator is responsible for ensuring the facility meets cGMP requirements — even if you are a tenant, not the building owner. If the building infrastructure (plumbing, drainage, pest exclusion) doesn't meet FDA standards, you need to work with the landlord to remediate or relocate. FDA does not accept landlord responsibility as a defense for cGMP violations.
Our drains are frequently pooling water. Is that a compliance violation?
Yes — standing water in food production areas is a Listeria harborage risk and a cGMP violation under 21 CFR 117.37. Inadequate drainage is also one of the most commonly cited FDA 483 observations and an environmental monitoring trigger point. Remediation is required.
A note from Truli: Truli is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.
Last updated: April 2026. Reflects 21 CFR 117.20 and related cGMP provisions as of April 2026. Book a demo to see how Truli monitors food safety compliance.
