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Code · CFR · Title 21 — Food and Drugs · Part 117 — Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food · § 117.335

§ 117.335. Special requirements applicable to a written assurance.

124 words·~1 min read·/us/cfr/t21/s§ 117.335·

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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.
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