21 CFR 117.135
Preventive controls
21 CFR 117.135 is the regulation titled “Preventive controls” in 21 CFR Part 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food. Since 2021, 2 FDA warning letters have cited it.
- Letters citing it
- 2 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 101.3, in 1 letter
- Closed out
- 50% of these letters have a published close-out
Letters citing it, by year issued
All are drug letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 117.135 most often, as written in the letters.
- 1 letterthe FDA investigator did not observe any employees apply sanitizer after donning their gloves and before touching RTE products
- 1 letterthe FDA investigator observed a packaging employee using a frayed, ripped towel to wipe the surface of a scratched wooden packaging table and then wiping their gloved hands on the same towel. Without removing or…
- 1 letterthe FDA investigator observed spilled nuts on the floor of the freezer, beside cases holding macadamia nuts and almonds. During the inspection, your firm began to clean the spilled nuts, but the FDA investigator noted…
The regulation
Read the text of 21 CFR 117.135 (eCFR, as of Sep 1, 2026)
(a)(1) You must identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act.
(2) Preventive controls required by paragraph (a)(1) of this section include:
(i) Controls at critical control points (CCPs), if there are any CCPs; and
(ii) Controls, other than those at CCPs, that are also appropriate for food safety.
(b) Preventive controls must be written.
(c) Preventive controls include, as appropriate to the facility and the food:
(1) Process controls. Process controls include procedures, practices, and processes to ensure the control of parameters during operations such as heat processing, acidifying, irradiating, and refrigerating foods. Process controls must include, as appropriate to the nature of the applicable control and its role in the facility's food safety system:
(i) Parameters associated with the control of the hazard; and
(ii) The maximum or minimum value, or combination of values, to which any biological, chemical, or physical parameter must be controlled to significantly minimize or prevent a hazard requiring a process control.
(2) Food allergen controls. Food allergen controls include procedures, practices, and processes to control food allergens. Food allergen controls must include those procedures, practices, and processes employed for:
(i) Ensuring protection of food from allergen cross-contact, including during storage, handling, and use; and
(ii) Labeling the finished food, including ensuring that the finished food is not misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act.
(3) Sanitation controls. Sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens, biological hazards due to employee handling, and food allergen hazards. Sanitation controls must include, as appropriate to the facility and the food, procedures, practices, and processes for the:
(i) Cleanliness of food-contact surfaces, including food-contact surfaces of utensils and equipment;
(ii) Prevention of allergen cross-contact and cross-contamination from insanitary objects and from personnel to food, food packaging material, and other food-contact surfaces and from raw product to processed product.
(4) Supply-chain controls. Supply-chain controls include the supply-chain program as required by subpart G of this part.
(5) Recall plan. Recall plan as required by § 117.139.
(6) Other controls. Preventive controls include any other procedures, practices, and processes necessary to satisfy the requirements of paragraph (a) of this section. Examples of other controls include hygiene training and other current good manufacturing practices.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 117.135.
- 21 CFR 101.3Identity labeling of food in packaged form1 letter cites both
- 21 CFR 101.4Food; designation of ingredients1 letter cites both
- 21 CFR 101.5Food; name and place of business of manufacturer, packer, or distributor1 letter cites both
- 21 CFR 101.54Nutrient content claims for “good source,” “high,” “more,” and “high potency.”1 letter cites both
- 21 CFR 101.7Declaration of net quantity of contents1 letter cites both
- 21 CFR 101.9Nutrition labeling of food1 letter cites both
- 21 CFR 117.126Food safety plan1 letter cites both
- 21 CFR 117.130Hazard analysis1 letter cites both
Latest letters citing it
The 2 letters citing 21 CFR 117.135 that FDA posted most recently.
- DrugsView Dough-To-Go, Inc.Baked goods and unbaked doughs, including Linzer Heart cookiesIssuedMay 12, 2026PostedJun 2, 2026
- DrugsView Lone Star Botanicals Inc.ready-to-eat seasoning blends and Dr. Botanical Health superfood powdersIssuedNov 6, 2023PostedJan 2, 2024
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Counts include every citation in a letter, as the Letters filter does. How this database is built.