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Code · CFR · Title 21 — Food and Drugs · Part 1 — General Enforcement Regulations · § 1.666

§ 1.666. How do I request reaccreditation?

170 words·~1 min read·/us/cfr/t21/s§ 1.666

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(a)Application following withdrawal. FDA will reinstate the accreditation of a third-party certification body for which it has withdrawn accreditation:
(1)If, in the case of direct accreditation, FDA determines, based on evidence presented by the third-party certification body, that the third-party certification body satisfies the applicable requirements of this subpart and adequate grounds for withdrawal no longer exist; or
(2)In the case of a third-party certification body accredited by an accreditation body for which recognition has been revoked under § 1.634:
(i)If the third-party certification body becomes accredited by another recognized accreditation body or by FDA through direct accreditation no later than 1 year after withdrawal of accreditation, or the original date of the expiration of accreditation, whichever comes first; or
(ii)Under such conditions as FDA may impose in withdrawing accreditation.
(b)Application following voluntary relinquishment. A third-party certification body that previously relinquished its accreditation under § 1.665 may seek accreditation by submitting a new application for accreditation under § 1.660 or, where applicable, § 1.670.
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