• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

  • Print
  • Share
  • E-mail
-

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).

New Search
Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2017]
[CITE: 21CFR1.634]



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 Recognition of Accreditation Bodies Under This Subpart

Sec. 1.634 When will FDA revoke recognition?

(a) Grounds for revocation of recognition. FDA will revoke the recognition of an accreditation body found not to be in compliance with the requirements of this subpart, including for any one or more of the following:

(1) Refusal by the accreditation body to allow FDA to access records required by 1.625, or to conduct an assessment or investigation of the accreditation body or of a third-party certification body it accredited to ensure the accreditation body's continued compliance with the requirements of this subpart.

(2) Failure to take timely and necessary corrective action when:

(i) The accreditation of a third-party certification body it accredited is withdrawn by FDA under 1.664(a);

(ii) A significant deficiency is identified through self-assessment under 1.622, monitoring under 1.621, or self-assessment by one or more of its accredited third-party certification bodies under 1.655; or

(iii) Directed to do so by FDA to ensure compliance with this subpart.

(3) A determination by FDA that the accreditation body has committed fraud or has submitted material false statements to the Agency.

(4) A determination by FDA that there is otherwise good cause for revocation, including:

(i) Demonstrated bias or lack of objectivity when conducting activities under this subpart; or

(ii) Failure to adequately support one or more decisions to grant accreditation under this subpart.

(iii) Failure to pay the annual user fee within 90 days of the payment due date, as specified in 1.725(b)(3).

(b) Records request associated with revocation. To assist in determining whether revocation is warranted under paragraph (a) of this section, FDA may request records of the accreditation body required by 1.625 or the records, required by 1.658, of one or more of the third-party certification bodies it accredited under this subpart.

(c) Issuance of revocation of recognition. (1) FDA will notify an accreditation body that its recognition has been revoked through issuance of a revocation that will state the grounds for revocation, the procedures for requesting a regulatory hearing under 1.693 on the revocation, and the procedures for requesting reinstatement of recognition under 1.636.

(2) Within 10 business days of the date of issuance of the revocation, the accreditation body must notify FDA electronically, in English, of the name of the custodian who will maintain the records and make them available to FDA as required by 1.625. The contact information for the custodian must provide, at a minimum, an email address and the physical address where the records will be located.

(d) Effect of revocation of recognition of an accreditation body on accredited third-party certification bodies. (1) FDA will issue a notice of the revocation of recognition to any accredited third-party certification body accredited by the accreditation body whose recognition was revoked. The third-party certification body's accreditation will remain in effect if the third-party certification body:

(i) No later than 60 days after FDA's issuance of the notice of revocation, conducts a self-assessment under 1.655 and reports the results of the self-assessment to FDA under 1.656(b); and

(ii) No later than 1 year after issuance of the notice of the revocation, or the original date of expiration of the accreditation, whichever comes first, becomes accredited by another recognized accreditation body or by FDA through direct accreditation.

(2) FDA may withdraw the accreditation of a third-party certification body whenever FDA determines there is good cause for withdrawal of accreditation under 1.664(c).

(e) Effect of revocation of recognition of an accreditation body on food or facility certifications issued to eligible entities. A food or facility certification issued by a third-party certification body accredited by a recognized accreditation body prior to issuance of the revocation of recognition will remain in effect until the certificate terminates by expiration. If FDA has reason to believe that a certification issued for purposes of section 801(q) or 806 of the FD&C Act is not valid or reliable, FDA may refuse to consider the certification in determining the admissibility of the article of food for which the certification was offered or in determining the importer's eligibility for participation in VQIP.

(f) Public notice of revocation of recognition. FDA will provide notice on the Web site described in 1.690 of the issuance of the revocation of recognition of an accreditation body and will describe the basis for revocation.

[80 FR 74650, Nov. 27, 2015, as amended at 81 FR 90193, Dec. 14, 2016]

-
-