Section 1.623 - What reports and notifications must a recognized accreditation body submit to FDA?(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: (i) The basis for such action; and(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: (i) The basis for such determination; and(ii) Any changes to accreditation information previously submitted to FDA under paragraph (c)(1) of this section.(d)Other notification to FDA. A recognized accreditation body must notify FDA electronically, in English, within 30 days after:(1) Denying accreditation (in whole or in part) under this subpart and include: (i) The name, address, telephone number, and email address of the third-party certification body;(ii) The name of one or more officers of the third-party certification body;(iii) The scope of accreditation requested; and(iv) The scope and basis for such denial.(2) Making any significant change that would affect the manner in which it complies with the applicable requirements of this subpart and include: (i) A description of the change; and(ii) An explanation for the purpose of the change.