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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: 21CFR1.653]



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 Third-Party Certification Bodies That Have Been Accredited Under This Subpart

Sec. 1.653 What must an accredited third-party certification body do when issuing food or facility certifications?

(a) Basis for issuance of a food or facility certification. (1) Prior to issuing a food or facility certification to an eligible entity, an accredited third-party certification body (or, where applicable, an audit agent on its behalf) must complete a regulatory audit that meets the requirements of 1.651 and any other activities that may be necessary to determine compliance with the applicable food safety requirements of the FD&C Act and FDA regulations.

(2) If, as a result of an observation during a regulatory audit, an eligible entity must implement a corrective action plan to address a deficiency, an accredited third-party certification body may not issue a food or facility certification to such entity until after the accredited third-party certification body verifies that eligible entity has implemented the corrective action plan through methods that reliably verify the corrective action was taken and as a result the identified deficiency is unlikely to recur, except onsite verification is required for corrective actions required to address deficiencies that are the subject of a notification under 1.656(c).

(3) An accredited third-party certification body must consider each observation and the data and other information from a regulatory audit and other activities conducted under 1.651 to determine whether the entity was in compliance with the applicable food safety requirements of the FD&C Act and FDA regulations at the time of the audit and whether the eligible entity, given its food safety system and practices, would be likely to remain in compliance for the duration of any certification issued under this subpart.

(4) A single regulatory audit may result in issuance of one or more food or facility certifications under this subpart, provided that the requirements of issuance are met as to each such certification.

(5) Where an accredited third-party certification body uses an audit agent to conduct a regulatory audit of an eligible entity under this subpart, the accredited third-party certification body (and not the audit agent) must make the determination whether to issue a food or facility certification based on the results of such regulatory audit.

(b) Issuance of a food or facility certification and submission to FDA. (1) Any food or facility certification issued under this subpart must be submitted to FDA electronically and in English. The accredited third-party certification body may issue a food or facility certification under this subpart for a term of up to 12 months.

(2) A food or facility certification must contain, at a minimum, the following elements:

(i) The name and address of the accredited third-party certification body and the scope and date of its accreditation under this subpart;

(ii) The name, address, FDA Establishment Identifier, and unique facility identifier, if designated by FDA, of the eligible entity to which the food or facility certification was issued;

(iii) The name, address, FDA Establishment Identifier, and unique facility identifier, if designated by FDA, of the facility where the regulatory audit was conducted, if different than the eligible entity;

(iv) The scope and date(s) of the regulatory audit and the certification number;

(v) The name of the audit agent(s) (where applicable) conducting the regulatory audit; and

(vi) The scope of the food or facility certification, date of issuance, and date of expiration.

(3) FDA may refuse to accept any certification for purposes of section 801(q) or 806 of the FD&C Act, if FDA determines, that such food or facility certification is not valid or reliable because, for example:

(i) The certification is offered in support of the admissibility of a food that was not within the scope of the certification;

(ii) The certification was issued by an accredited third-party certification body acting outside the scope of its accreditation under this subpart; or

(iii) The certification was issued without reliable demonstration that the requirements of paragraph (a) of this section were met.

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