21 CFR 117.160
Validation
21 CFR 117.160 is the regulation titled “Validation” 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 117.160 (eCFR, as of Sep 1, 2026)
(a) You must validate that the preventive controls identified and implemented in accordance with § 117.135 are adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility's food safety system.
(b) The validation of the preventive controls:
(1) Must be performed (or overseen) by a preventive controls qualified individual:
(i)(A) Prior to implementation of the food safety plan; or
(B) When necessary to demonstrate the control measures can be implemented as designed:
(1) Within 90 calendar days after production of the applicable food first begins; or
(2) Within a reasonable timeframe, provided that the preventive controls qualified individual prepares (or oversees the preparation of) a written justification for a timeframe that exceeds 90 calendar days after production of the applicable food first begins;
(ii) Whenever a change to a control measure or combination of control measures could impact whether the control measure or combination of control measures, when properly implemented, will effectively control the hazards; and
(iii) Whenever a reanalysis of the food safety plan reveals the need to do so;
(2) Must include obtaining and evaluating scientific and technical evidence (or, when such evidence is not available or is inadequate, conducting studies) to determine whether the preventive controls, when properly implemented, will effectively control the hazards; and
(c) You do not need to validate:
(1) The food allergen controls in § 117.135(c)(2);
(2) The sanitation controls in § 117.135(c)(3);
(3) The recall plan in § 117.139;
(4) The supply-chain program in subpart G of this part; and
(5) Other preventive controls, if the preventive controls qualified individual prepares (or oversees the preparation of) a written justification that validation is not applicable based on factors such as the nature of the hazard, and the nature of the preventive control and its role in the facility's food safety system.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 117.160.
- 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 117.160 that FDA posted most recently.
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