CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

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

[Code of Federal Regulations]

[Title 21, Volume 1]

[CITE: 21CFR1.662]

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

Procedures for Accreditation of Third-Party Certification Bodies Under This Subpart

Sec. 1.662 How will FDA monitor accredited third-party certification bodies?

(a) FDA will periodically evaluate the performance of each accredited third-party certification body to determine whether the accredited third-party certification body continues to comply with the applicable requirements of this subpart and whether there are deficiencies in the performance of the accredited third-party certification body that, if not corrected, would warrant withdrawal of its accreditation under § 1.664. FDA will evaluate each directly accredited third-party certification body annually. For a third-party certification body accredited by a recognized accreditation body, FDA will evaluate an accredited third-party certification body not later than 3 years after the date of accreditation for a 4-year term of accreditation, or by no later than the mid-term point for accreditation granted for less than 4 years. FDA may conduct additional performance assessments of an accredited third-party certification body at any time.

(b) In evaluating the performance of an accredited third-party certification body under paragraph (a) of this section, FDA may review any one or more of the following:

(1) Regulatory audit reports and food and facility certifications;

(2) The accredited third-party certification body's self-assessments under § 1.655;

(3) Reports of assessments by a recognized accreditation body under § 1.621;

(4) Documents and other information relevant to a determination of the accredited third-party certification body's compliance with the applicable requirements of this subpart; and

(5) Information obtained by FDA, including during inspections, audits, onsite observations, or investigations, of one or more eligible entities to which a food or facility certification was issued by such accredited third-party certification body.

(c) FDA may conduct its evaluation of an accredited third-party certification body through a site visit to an accredited third-party certification body's headquarters (or other location that manages audit agents conducting food safety audits under this subpart, if different than its headquarters), through onsite observation of an accredited third party certification body's performance during a food safety audit of an eligible entity, or through document review.