21 CFR §507.215
Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
- (a)Any written assurance required by this part must contain the following elements:
- (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.