21 CFR 507.215
§ 507.215 Special requirements applicable to a written assurance.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 507.215, § 507.215 Special requirements applicable to a written assurance, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86895
- Permanent ID
ys:prov:86895@1- SHA-256
cc23dd8a479c06755ef28d79146b659cbcf1cf17a084e5b75b3af9837fd7170d
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.