21 CFR 820.22: Quality audit
Required manufacturers to establish procedures and conduct quality audits by independent personnel to verify quality system compliance and effectiveness, take corrective action and reaudit deficiencies, have responsible management review reports, and document audit dates and results.
Part 820, Quality System Regulation · Subpart B, Quality System Requirements
Most device 483s cite the Quality System Regulation in force before February 2, 2026, when the QMSR replaced it. Those sections are marked Former.
How FDA words it
The opening lines investigators use most when they cite 820.22, from the 483s we hold.
Procedures for quality audits have not been adequately established.Most used
Quality audits have not been performed.
Procedures for quality audits have not been established.
Cited over time
483s citing 820.22, by yearMost citations in 2024. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2024.
Recent 483s citing 820.22
- Seniorlife Technologies Inc · Bellevue, WashingtonInternal audits have not been adequately conducted at planned intervals to… Feb 20, 2026
- Amigo Mobility International, Inc. · —The selection of auditors and conduct of audits did not adequately ensure… Feb 5, 2026
- Marson Medical, Inc. · New JerseyIndividuals who conduct quality audits have direct responsibility for the matters… Jan 16, 2026
- Encore Laboratory · —Quality audits have not been performed… Jan 9, 2026
- ASEPTIKITS, LLC · North Salt Lake, UtahQuality audits have not been performed… Dec 3, 2025
The regulation text
§ 820.22 Quality audit. As published before it was replaced.
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.
Questions
What does 21 CFR 820.22 require?
Required manufacturers to establish procedures and conduct quality audits by independent personnel to verify quality system compliance and effectiveness, take corrective action and reaudit deficiencies, have responsible management review reports, and document audit dates and results.
How do FDA investigators word a 820.22 observation?
The most common opening is: “Procedures for quality audits have not been adequately established.”
Which sections are cited alongside 820.22?
In the same 483s, investigators most often also cite 820.100 (Corrective and preventive action), 820.20 (Management responsibility), 820.50 (Purchasing controls), 820.198 (Complaint files).