21 C.F.R. § 117.335

Special requirements applicable to a written assurance.

Last amended: 2016Year: 2026Length: 124 wordsSubsections: 4Official source

Cite as 21 C.F.R. § 117.335 (2026)

(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.
Cross-references to the CFR
117.136
21 C.F.R. § 117.335: Special requirements applicable to a written assurance. | Justis AI