21 CFR §117.335

1. (a)Any written assurance required by this part must contain the following elements:
   1. (1)Effective date;
   2. (2)Printed names and signatures of authorized officials;
   3. (3)The applicable assurance under:
      1. (i)Section 117.136(a)(2);
      2. (ii)Section 117.136(a)(3);
      3. (iii)Section 117.136(a)(4);
      4. (iv)Section 117.430(c)(2);
      5. (v)Section 117.430(d)(2); or
      6. (vi)Section 117.430(e)(2);
2. (b)A written assurance required under § 117.136(a)(2), (3), or (4) must include:
   1. (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. (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.