21 CFR 117.126
Food safety plan
21 CFR 117.126 is the regulation titled “Food safety plan” 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 117.126 (eCFR, as of Sep 1, 2026)
(a) Requirement for a food safety plan. (1) You must prepare, or have prepared, and implement a written food safety plan.
(2) The food safety plan must be prepared, or its preparation overseen, by one or more preventive controls qualified individuals.
(b) Contents of a food safety plan. The written food safety plan must include:
(1) The written hazard analysis as required by § 117.130(a)(2);
(2) The written preventive controls as required by § 117.135(b);
(3) The written supply-chain program as required by subpart G of this part;
(4) The written recall plan as required by § 117.139(a); and
(5) The written procedures for monitoring the implementation of the preventive controls as required by § 117.145(a);
(6) The written corrective action procedures as required by § 117.150(a)(1); and
(7) The written verification procedures as required by § 117.165(b).
(c) Records. The food safety plan required by this section is a record that is subject to the requirements of subpart F of this part.
[80 FR 56145, Sept. 17, 2015, as amended at 84 FR 12491, Apr. 2, 2019]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 117.126.
- 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 117.130Hazard analysis1 letter cites both
- 21 CFR 117.135Preventive controls1 letter cites both
Latest letters citing it
The letter citing 21 CFR 117.126 that FDA posted most recently.
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