---
kind: "section"
citation: "21 C.F.R. § 117.335"
title: "21"
number: "117.335"
heading: "Special requirements applicable to a written assurance."
url: "https://uscodex.org/cfr/21/117.335"
---

# §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)](/cfr/21/117.136.md?p=a-2);
    - (ii) [Section 117.136(a)(3)](/cfr/21/117.136.md?p=a-3);
    - (iii) [Section 117.136(a)(4)](/cfr/21/117.136.md?p=a-4);
    - (iv) [Section 117.430(c)(2)](/cfr/21/117.430.md?p=c-2);
    - (v) [Section 117.430(d)(2)](/cfr/21/117.430.md?p=d-2); or
    - (vi) [Section 117.430(e)(2)](/cfr/21/117.430.md?p=e-2);
- (b) A written assurance required under § [117.136(a)(2)](/cfr/21/117.136.md?p=a-2), [(3)](/cfr/21/117.136.md?p=a-3), or [(4)](/cfr/21/117.136.md?p=a-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.

## Notes

### Authority

Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271.

### Source

Source: 80 FR 56145, Sept. 17, 2015, unless otherwise noted.