21 CFR 117.140
Preventive control management components
21 CFR 117.140 is the regulation titled “Preventive control management components” 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
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 101.3, in 1 letter
- Closed out
- 100% of these letters have a published close-out
Letters citing it, by year issued
It is a drug letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 12023
- 02024
- 02025
- 02026
The regulation
Read the text of 21 CFR 117.140 (eCFR, as of Sep 1, 2026)
(a) Except as provided by paragraphs (b) and (c) of this section, the preventive controls required under § 117.135 are subject to the following preventive control management components as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system:
(1) Monitoring in accordance with § 117.145;
(2) Corrective actions and corrections in accordance with § 117.150; and
(3) Verification in accordance with § 117.155.
(b) The supply-chain program established in subpart G of this part is subject to the following preventive control management components as appropriate to ensure the effectiveness of the supply-chain program, taking into account the nature of the hazard controlled before receipt of the raw material or other ingredient:
(1) Corrective actions and corrections in accordance with § 117.150, taking into account the nature of any supplier non-conformance;
(2) Review of records in accordance with § 117.165(a)(4); and
(3) Reanalysis in accordance with § 117.170.
(c) The recall plan established in § 117.139 is not subject to the requirements of paragraph (a) of this section.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 117.140.
- 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 letter citing 21 CFR 117.140 that FDA posted most recently.
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