21 CFR 112.161
§ 112.161 What general requirements apply to records required under this part?
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 112.161, § 112.161 What general requirements apply to records required under this part?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/84307
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.