§ 1.623. What reports and notifications must a recognized accreditation body submit to FDA?

455 words·~2 min read·/us/cfr/t21/s§ 1.623

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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:

(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.