21 CFR § 117.335 - Special requirements applicable to a written assurance.

---
identifier: "/us/cfr/t21/s117.335"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 117.335 - Special requirements applicable to a written assurance."
title_number: 21
title_name: "Food and Drugs"
section_number: "117.335"
section_name: "Special requirements applicable to a written assurance."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "B"
subchapter_name: "FOOD FOR HUMAN CONSUMPTION"
part_number: "117"
part_name: "CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD"
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. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271."
regulatory_source: "80 FR 56145, Sept. 17, 2015, unless otherwise noted."
cfr_part: "117"
---


# 117.335 Special requirements applicable to a written assurance.

(a) Any written assurance required by this part must contain the following elements:

(1) Effective date;

(2) Printed names and signatures of authorized officials;

(3) The applicable assurance under:

(i) Section 117.136(a)(2);

(ii) Section 117.136(a)(3);

(iii) Section 117.136(a)(4);

(iv) Section 117.430(c)(2);

(v) Section 117.430(d)(2); or

(vi) Section 117.430(e)(2);

(b) A written assurance required under § 117.136(a)(2), (3), or (4) must include:

(1) Acknowledgement that the facility that provides the written assurance assumes legal responsibility to act consistently with the assurance and document its actions taken to satisfy the written assurance; and

(2) Provision that if the assurance is terminated in writing by either entity, responsibility for compliance with the applicable provisions of this part reverts to the manufacturer/processor as of the date of termination.