21 CFR § 112.161 - What general requirements apply to records required under this part?

---
identifier: "/us/cfr/t21/s112.161"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 112.161 - What general requirements apply to records required under this part?"
title_number: 21
title_name: "Food and Drugs"
section_number: "112.161"
section_name: "What general requirements apply to records required under this part?"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "B"
subchapter_name: "FOOD FOR HUMAN CONSUMPTION"
part_number: "112"
part_name: "STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243, 264, 271."
regulatory_source: "80 FR 74547, Nov. 27, 2015, unless otherwise noted."
cfr_part: "112"
---


# 112.161 What general requirements apply to records required under this part?

(a) Except as otherwise specified, all records required under this part must:

(1) Include, as applicable:

(i) The name and location of your farm;

(ii) Actual values and observations obtained during monitoring;

(iii) An adequate description (such as the commodity name, or the specific variety or brand name of a commodity, and, when available, any lot number or other identifier) of covered produce applicable to the record;

(iv) The location of a growing area (for example, a specific field) or other area (for example, a specific packing shed) applicable to the record; and

(v) The date and time of the activity documented;

(2) Be created at the time an activity is performed or observed;

(3) Be accurate, legible, and indelible; and

(4) Be dated, and signed or initialed by the person who performed the activity documented.

(b) Records required under §§ 112.7(b); 112.30(b); 112.50(b)(2), (5), (7), and (11); 112.60(b)(2); 112.140(b)(1) and (2); and 112.150(b)(1), (4), and (6) must be reviewed, dated, and signed, within a reasonable time after the records are made, by a supervisor or responsible party.

[80 FR 74547, Nov. 27, 2015, as amended at 84 FR 12491, Apr. 2, 2019; 89 FR 37519, May 6, 2024]