{"data":{"id":"us/21-cfr-1.623","jurisdiction":"us","citation":"21 CFR 1.623","heading":"What reports and notifications must a recognized accreditation body submit to FDA?","body":"(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.\n(b) Reporting results of recognized accreditation body self-assessments. A recognized accreditation body must submit to FDA electronically, in English:\n(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\n(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.\n(c) Immediate notification to FDA. A recognized accreditation body must notify FDA electronically, in English, immediately upon:\n(1) Granting (including expanding the scope of) accreditation to a third-party certification body under this subpart, and include:\n(i) The name, address, telephone number, and email address of the accredited third-party certification body;\n(ii) The name of one or more officers of the accredited third-party certification body;\n(iii) A list of the accredited third-party certification body's audit agents; and\n(iv) The scope of accreditation, the date on which it was granted, and its expiration date.\n(2) Withdrawing, suspending, or reducing the scope of an accreditation under this subpart, and include:\n(i) The basis for such action; and\n(ii) Any additional changes to accreditation information previously submitted to FDA under paragraph (c)(1) of this section.\n(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:\n(i) The basis for such determination; and\n(ii) Any changes to accreditation information previously submitted to FDA under paragraph (c)(1) of this section.\n(d) Other notification to FDA. A recognized accreditation body must notify FDA electronically, in English, within 30 days after:\n(1) Denying accreditation (in whole or in part) under this subpart and include:\n(i) The name, address, telephone number, and email address of the third-party certification body;\n(ii) The name of one or more officers of the third-party certification body;\n(iii) The scope of accreditation requested; and\n(iv) The scope and basis for such denial.\n(2) Making any significant change that would affect the manner in which it complies with the applicable requirements of this subpart and include:\n(i) A description of the change; and\n(ii) An explanation for the purpose of the change.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER A—GENERAL","PART 1—GENERAL ENFORCEMENT REGULATIONS","Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"bebd72a3b7a46f7e42dcf5db2ca670614845712062109f8e6290900826018d41","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-1.622","next":"us/21-cfr-1.624"},"notice":"GroundRules: Original legal text. Not legal advice."}