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21 CFR Part 820 · Quality Management System Regulation

§ 820.22 Quality audit

Subpart B - Supplemental Provisions Official text on eCFR
Removed from 21 CFR. The Quality Management System Regulation (QMSR) replaced the Quality System Regulation on 2 Feb 2026. Removed by the Quality Management System Regulation, effective 2 February 2026: Part 820 now incorporates ISO 13485:2016 by reference (§ 820.7) and requires it in § 820.10. See § 820.10. The text below is the former QSR wording, kept for reference.

Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s), including a reaudit of deficient matters, shall be taken when necessary. A report of the results of each quality audit, and reaudit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and reaudits shall be documented.

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

What FDA inspectors cite under § 820.22

Form FDA 483 observations citing this section, fiscal years 2009–2026 (Devices).

  • Quality audits - Lack of or inadequate procedures 1,011
  • Quality Audit/Reaudit - conducted 528
  • Quality Audits - defined intervals 318
  • Quality audits - auditor independence 243
  • Quality Audit/Reaudit - documentation 33
  • Quality audit - audit report review 11

Warning letters citing § 820.22

55 FDA warning letters since 2017 cite this section ; the most recent:

FDA guidance that cites § 820.22