21 CFR Part 117 · Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food

21 CFR 117.20

Plant and grounds

21 CFR 117.20 is the regulation titled “Plant and grounds” in 21 CFR Part 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food. Since 2021, 1 FDA warning letter has cited it.

Letters citing it
1 since 2021
Jan 1 to Oct 30, 2026
1 against 0 on the same dates in 2025
Most often cited with
21 CFR 117.135, in 1 letter
Closed out
0% of these letters have a published close-out
See the letter citing 21 CFR 117.20 →

Letters citing it, by year issued

It is a drug letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.

  1. 02021
  2. 02022
  3. 02023
  4. 02024
  5. 02025
  6. 12026

What FDA writes when it cites it

The finding headings that cite 21 CFR 117.20 most often, as written in the letters.

  • 1 letterthe FDA investigator observed overgrown weeds, other vegetation, and unused equipment stored directly outside the building (near the employee entrance and outdoor break area). Overgrown vegetation and equipment that is…

The regulation

Read the text of 21 CFR 117.20 (eCFR, as of Sep 1, 2026)

(a) Grounds. The grounds about a food plant under the control of the operator must be kept in a condition that will protect against the contamination of food. The methods for adequate maintenance of grounds must include:

(1) Properly storing equipment, removing litter and waste, and cutting weeds or grass within the immediate vicinity of the plant that may constitute an attractant, breeding place, or harborage for pests.

(2) Maintaining roads, yards, and parking lots so that they do not constitute a source of contamination in areas where food is exposed.

(3) Adequately draining areas that may contribute contamination to food by seepage, foot-borne filth, or providing a breeding place for pests.

(4) Operating systems for waste treatment and disposal in an adequate manner so that they do not constitute a source of contamination in areas where food is exposed.

(5) If the plant grounds are bordered by grounds not under the operator's control and not maintained in the manner described in paragraphs (a)(1) through (4) of this section, care must be exercised in the plant by inspection, extermination, or other means to exclude pests, dirt, and filth that may be a source of food contamination.

(b) Plant construction and design. The plant must be suitable in size, construction, and design to facilitate maintenance and sanitary operations for food-production purposes (i.e., manufacturing, processing, packing, and holding). The plant must:

(1) Provide adequate space for such placement of equipment and storage of materials as is necessary for maintenance, sanitary operations, and the production of safe food.

(2) Permit the taking of adequate precautions to reduce the potential for allergen cross-contact and for contamination of food, food-contact surfaces, or food-packaging materials with microorganisms, chemicals, filth, and other extraneous material. The potential for allergen cross-contact and for contamination may be reduced by adequate food safety controls and operating practices or effective design, including the separation of operations in which allergen cross-contact and contamination are likely to occur, by one or more of the following means: location, time, partition, air flow systems, dust control systems, enclosed systems, or other effective means.

(3) Permit the taking of adequate precautions to protect food in installed outdoor bulk vessels by any effective means, including:

(i) Using protective coverings.

(ii) Controlling areas over and around the vessels to eliminate harborages for pests.

(iii) Checking on a regular basis for pests and pest infestation.

(iv) Skimming fermentation vessels, as necessary.

(4) Be constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair; that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials; and that aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating food, food-contact surfaces, or food-packaging materials with clothing or personal contact.

(5) Provide adequate lighting in hand-washing areas, dressing and locker rooms, and toilet rooms and in all areas where food is examined, manufactured, processed, packed, or held and where equipment or utensils are cleaned; and provide shatter-resistant light bulbs, fixtures, skylights, or other glass suspended over exposed food in any step of preparation or otherwise protect against food contamination in case of glass breakage.

(6) Provide adequate ventilation or control equipment to minimize dust, odors and vapors (including steam and noxious fumes) in areas where they may cause allergen cross-contact or contaminate food; and locate and operate fans and other air-blowing equipment in a manner that minimizes the potential for allergen cross-contact and for contaminating food, food-packaging materials, and food-contact surfaces.

(7) Provide, where necessary, adequate screening or other protection against pests.

Text from eCFR as of Sep 1, 2026.

Cited alongside it

Regulations that appear in the same letters as 21 CFR 117.20.

Latest letters citing it

The letter citing 21 CFR 117.20 that FDA posted most recently.

See the letter citing 21 CFR 117.20 →
For regulated teams

Put this kind of reading to
work on your own records.

Botable builds and runs a custom AI layer around the software you already use, so your team can do the job you hired them for.

Counts include every citation in a letter, as the Letters filter does. How this database is built.

Every letter by dateHow this database is built

FDA Warning Letter Alerts

Share this view

Send the same filters, search and view to a colleague.

You choose what to post or send. Sharing a link does not change access to this site.