21 C.F.R. § 507.215

Current through May 31, 2024
Section 507.215 - 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) § 507.36(a)(2) ;
(ii) § 507.36(a)(3) ;
(iii) § 507.36(a)(4) ;
(iv) § 507.130(c)(2) ;
(v) § 507.130(d)(2) ; or
(vi) § 507.130(e)(2) .
(b) A written assurance required under § 507.36(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. §507.215