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21 CFR 117.335

§ 117.335 Special requirements applicable to a written assurance.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 117.335, § 117.335 Special requirements applicable to a written assurance, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/84434
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(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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.