21 CFR 820.100: Corrective and preventive action
Manufacturers had to maintain documented CAPA procedures to analyze quality data, investigate causes, take and verify effective corrective and preventive actions, share information with responsible staff, and report to management review.
Part 820, Quality System Regulation · Subpart J, Corrective and Preventive Action
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 820.100, from the 483s we hold.
Procedures for corrective and preventive action have not been adequately established.Most used
Corrective and preventive action activities and/or results have not been adequately documented.820.100(b)
Procedures for corrective and preventive action have not been established.820.100(a)
Cited over time
483s citing 820.100, 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 820.100
- Nanovis LLC · Columbia City, IndianaChanges necessary to ensure and maintain the continued suitability, adequacy, and… Mar 19, 2026
- Amigo Mobility International, Inc. · —Corrective action procedures defining the requirements for determining the causes… Feb 5, 2026
- Marson Medical, Inc. · New JerseyProcedures for corrective and preventive action have not been adequately… Jan 16, 2026
- MIDWAY MEDICAL · Bloomington, IllinoisProcedures for corrective and preventive action have not been established… Jan 15, 2026
- ZIIP INC · Pleasant Hill, CaliforniaEUPLOVE,S) SGNATURE DATENSSUED Procedures for corrective and preventive action have… Jan 12, 2026
The regulation text
§ 820.100 Corrective and preventive action. As published before it was replaced.
(a)Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for:
(1)Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems;
(2)Investigating the cause of nonconformities relating to product, processes, and the quality system;
(3)Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems;
(4)Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device;
(5)Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;
(6)Ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems; and
(7)Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.
(b)All activities required under this section, and their results, shall be documented.
Questions
What does 21 CFR 820.100 require?
Manufacturers had to maintain documented CAPA procedures to analyze quality data, investigate causes, take and verify effective corrective and preventive actions, share information with responsible staff, and report to management review.
How do FDA investigators word a 820.100 observation?
The most common opening is: “Procedures for corrective and preventive action have not been adequately established.”
Which sections are cited alongside 820.100?
In the same 483s, investigators most often also cite 820.198 (Complaint files), 820.30 (Design controls), 820.50 (Purchasing controls), 820.75 (Process validation).