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Notes

§507.215. Special requirements applicable to a written assurance.

21 C.F.R. § 507.215

(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)
(ii)
(iii)
(iv)
(v)
(vi)
(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.
Notes, amendments, and revision history

Authority

Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271.

Source

Source: 80 FR 56337, Sept. 17, 2015, unless otherwise noted.