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https://www.federalregister.gov/articles/2015/09/17/2015-21920/current-good-manufacturing-…

… effective September 17, 2018 and paragraph (2) of the definition of "qualified auditor" in Sec. 117.3, and Sec. Sec. 117.5(k)(2), 117.8, 117.405(a)(2), 117.405(c), 117.410(d)(2)(ii), 117.430(d), 117.435(d), 117.475(c)(2) and 117.475(c)(13). FDA will publish a document in the Fed…

https://www.federalregister.gov/documents/2026/02/11/2026-02769/patient-protection-and-aff…

…audits are collaborative, meaning at any point issuers can ask questions of the auditors or seek clarification on the information or documentation needed. Further, in conjunction with these audit processes and in accordance with § 156.806, when imposing a CMP, HHS must provide wr…