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Title 21: Food and Drugs
§ 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.

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