cfr_sections: 21:21:1.0.1.1.1.12.67.23
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This data as json
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| 21:21:1.0.1.1.1.12.67.23 | 21 | Food and Drugs | I | A | 1 | PART 1—GENERAL ENFORCEMENT REGULATIONS | M | Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications | 1.641 | § 1.641 What legal authority must a third-party certification body have to qualify for accreditation? | FDA | 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216, 241, 243, 262, 264, 271. | 80 FR 74650, Nov. 27, 2015, unless otherwise noted. | (a) A third-party certification body seeking accreditation from a recognized accreditation body or from FDA must demonstrate that it has the authority (as a governmental entity or as a legal entity with contractual rights) to perform such examinations of facilities, their process(es), and food(s) as are necessary to determine compliance with the applicable food safety requirements of the FD&C Act and FDA regulations, and conformance with applicable industry standards and practices and to issue certifications where appropriate based on a review of the findings of such examinations. This includes authority to: (1) Review any relevant records; (2) Conduct onsite audits of an eligible entity; and (3) Suspend or withdraw certification for failure to comply with applicable requirements. (b) A third-party certification body seeking accreditation must demonstrate that it is capable of exerting the authority (as a governmental entity or as legal entity with contractual rights) necessary to meet the applicable requirements of accreditation under this subpart if accredited. |