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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2017.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2017]
[CITE: 21CFR1.623]



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

Requirements for Accreditation Bodies That Have Been Recognized Under This Subpart

Sec. 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.

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