GroundRules
21 CFR 1.642: What competency and capacity must a third-party certification body have to qualify for accreditation?
Where this section sits in the code
- 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
A third-party certification body seeking accreditation must demonstrate that it has:
(a) The resources necessary to fully implement its certification program, including:
(1) Adequate numbers of employees and other agents with relevant knowledge, skills, and experience to effectively examine for compliance with applicable FDA food safety requirements of the FD&C Act and FDA regulations, conformance with applicable industry standards and practices, and issuance of valid and reliable certifications; and
(2) Adequate financial resources for its operations; and
(b) The competency and capacity to meet the applicable requirements of this subpart, if accredited.
Collected 2026-08-27T02:24:47Z. Source file · JSON