21 CFR 117.145
Monitoring
21 CFR 117.145 is the regulation titled “Monitoring” 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 117.145 (eCFR, as of Sep 1, 2026)
As appropriate to the nature of the preventive control and its role in the facility's food safety system:
(a) Written procedures. You must establish and implement written procedures, including the frequency with which they are to be performed, for monitoring the preventive control; and
(b) Monitoring. You must monitor the preventive controls with adequate frequency to provide assurance that they are consistently performed.
(c) Records. (1) Requirement to document monitoring. You must document the monitoring of preventive controls in accordance with this section in records that are subject to verification in accordance with § 117.155(a)(2) and records review in accordance with § 117.165(a)(4)(i).
(2) Exception records. (i) Records of refrigeration temperature during storage of food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin production by, pathogens may be affirmative records demonstrating temperature is controlled or exception records demonstrating loss of temperature control.
(ii) Exception records may be adequate in circumstances other than monitoring of refrigeration temperature.
[80 FR 56145, Sept. 17, 2015, as amended at 81 FR 3716, Jan. 22, 2016]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 117.145.
- 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 117.145 that FDA posted most recently.
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