21 CFR 820.22
Quality audit
21 CFR 820.22 is the regulation titled “Quality audit” in 21 CFR Part 820, Quality System Regulation (before Feb 2, 2026). Since 2021, 26 FDA warning letters have cited it.
Part 820 changed when FDA's Quality Management System Regulation took effect on February 2, 2026. This is the earlier text these letters cite.
- Letters citing it
- 26 since 2021
- Jan 1 to Oct 30, 2026
- 4 against 8 on the same dates in 2025
- Most often cited with
- 21 CFR 807.81, in 21 letters
- Closed out
- 19% of these letters have a published close-out
Letters citing it, by year issued
Most are medical device letters (25 of 26). 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 820.22 most often, as written in the letters.
- 2 lettersFailure to 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…
- 1 letterFailure to adequately establish procedures for quality audits and conduct such audits to ensure that the quality system is in compliance with the established quality system requirements and to determine the…
- 1 letterFailure to adequately establish procedures for quality audits, as required by 21 CFR 820.22
The regulation
Read the text of 21 CFR 820.22 (eCFR, as of Jun 1, 2025)
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.
Text from eCFR as of Jun 1, 2025.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 820.22.
- 21 CFR 807.81When a premarket notification submission is required21 letters cite both
- 21 CFR 820.30Design controls20 letters cite both
- 21 CFR 820.198Complaint files19 letters cite both
- 21 CFR 820.100Corrective and preventive action18 letters cite both
- 21 CFR 820.50Purchasing controls18 letters cite both
- 21 CFR 820.20Management responsibility15 letters cite both
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?14 letters cite both
- 21 CFR 820.80Receiving, in-process, and finished device acceptance14 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 820.22 that FDA posted most recently.
- DevicesView Chirp Innovations, LLCChirp Halo Wireless Muscle StimulatorIssuedOct 2, 2026PostedOct 27, 2026
- DevicesView Peter Schiff Enterprisescardiac electrode pads and AC cardiac fibrillatorsIssuedAug 26, 2026PostedOct 27, 2026
- DevicesView BlephEx, LLCBlephEx Powered Eyelid Cleaning Sponge, OptiVize Ophthalmic Battery-Powered Electrolysis Unit, OptiVize Ophthalmic ForcepsIssuedJun 3, 2026PostedJul 7, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.