21 C.F.R. · Food and Drugs
21 C.F.R. § 507.215

Special requirements applicable to a written assurance.

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 507.215 — Special requirements applicable to a written assurance.

§ 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.

Source: ecfr.gov · govinfo.gov — public domain Official Source ↗
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21 C.F.R. § 507.215
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The regulatory text of 21 C.F.R. § 507.215 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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