Qualitied Auditor US

In the September 19, 2016, Federal Register, FDA announced the effective date for the definition of “qualified auditor” included in 21 C.F.R. § 117.3 (80 FR 55098 at 56147) and § 507.3 (80 FR 56170 at 56339). The definition of “qualified auditor” was included in the final rule for “Current Good Manufacturing Practices, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” of September 17, 2016, which reads, “An audit agent of a certification body that is accredited in accordance with regulations in part 1, subpart M of this chapter.” The preamble of the rule stated that FDA would announce the effective date for the definition once it finalized the rule, “Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits to Issue Certifications.” Such final rule was published on November 27, 2015, with an effective date of January 26, 2016, and thus FDA announced the definition’s effective date was September 19, 2016.

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