21 C.F.R. § 117.335

Current through October 31, 2024
Section 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.

21 C.F.R. §117.335