subpart_subject: "Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications"
section_number: "1.623"
section_subject: "What reports and notifications must a recognized accreditation body submit to FDA?"
cfr_reference: "21 CFR 1.623"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 1 to 99"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)Reporting results of assessments of accredited third-party certification body performance. A recognized accreditation body must submit to FDA electronically, in English, a report of the results of any assessment conducted under § 1.621, no later than 45 days after completing such assessment. The report must include an up-to-date list of any audit agents used by the accredited third-party certification body to conduct food safety audits under this subpart.
(b)Reporting results of recognized accreditation body self-assessments. A recognized accreditation body must submit to FDA electronically, in English:
(1)A report of the results of an annual self-assessment required under § 1.622, no later than 45 days after completing such self-assessment; and
(2)For a recognized accreditation body subject to § 1.664(g)(1), a report of such self-assessment to FDA within 60 days of the third-party certification body's withdrawal. A recognized accreditation body may use a report prepared for conformance to ISO/IEC 17011:2004, supplemented as necessary, in meeting the requirements this section.
(c)Immediate notification to FDA. A recognized accreditation body must notify FDA electronically, in English, immediately upon:
(1)Granting (including expanding the scope of) accreditation to a third-party certification body under this subpart, and include:
(i)The name, address, telephone number, and email address of the accredited third-party certification body;
(ii)The name of one or more officers of the accredited third-party certification body;
(iii)A list of the accredited third-party certification body's audit agents; and
(iv)The scope of accreditation, the date on which it was granted, and its expiration date.
(2)Withdrawing, suspending, or reducing the scope of an accreditation under this subpart, and include:
(ii)Any additional changes to accreditation information previously submitted to FDA under paragraph (c)(1) of this section.
(3)Determining that a third-party certification body it accredited failed to comply with § 1.653 in issuing a food or facility certification under this subpart, and include: