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.

Reporting results of recognized accreditation body self-assessments. A recognized accreditation body must submit to FDA electronically, in English:

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

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.

Immediate notification to FDA. A recognized accreditation body must notify FDA electronically, in English, immediately upon:

Granting (including expanding the scope of) accreditation to a third-party certification body under this subpart, and include:

The name, address, telephone number, and email address of the accredited third-party certification body;

The name of one or more officers of the accredited third-party certification body;

A list of the accredited third-party certification body's audit agents; and

The scope of accreditation, the date on which it was granted, and its expiration date.

Withdrawing, suspending, or reducing the scope of an accreditation under this subpart, and include:

The basis for such action; and

Any additional changes to accreditation information previously submitted to FDA under paragraph (c)(1) of this section.

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:

The basis for such determination; and

Any changes to accreditation information previously submitted to FDA under paragraph (c)(1) of this section.

Other notification to FDA. A recognized accreditation body must notify FDA electronically, in English, within 30 days after:

Denying accreditation (in whole or in part) under this subpart and include:

The name, address, telephone number, and email address of the third-party certification body;

The name of one or more officers of the third-party certification body;

The scope of accreditation requested; and

The scope and basis for such denial.

Making any significant change that would affect the manner in which it complies with the applicable requirements of this subpart and include:

A description of the change; and

An explanation for the purpose of the change.