21 CFR 820.100
Corrective and preventive action
21 CFR 820.100 is the regulation titled “Corrective and preventive action” in 21 CFR Part 820, Quality System Regulation (before Feb 2, 2026). Since 2021, 105 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
- 105 since 2021
- Jan 1 to Oct 30, 2026
- 16 against 26 on the same dates in 2025
- Most often cited with
- 21 CFR 820.30, in 80 letters
- Closed out
- 13% of these letters have a published close-out
Letters citing it, by year issued
Most are medical device letters (104 of 105). 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 820.100 most often, as written in the letters.
- 6 lettersFailure to adequately establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a)
- 4 lettersFailure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a)
- 2 lettersFailure to adequately establish and maintain procedures for corrective and preventive action, as required by 21 CFR 820.100(a)
The regulation
Read the text of 21 CFR 820.100 (eCFR, as of Jun 1, 2025)
(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.
Text from eCFR as of Jun 1, 2025.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 820.100.
- 21 CFR 820.30Design controls80 letters cite both
- 21 CFR 820.198Complaint files66 letters cite both
- 21 CFR 807.81When a premarket notification submission is required42 letters cite both
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?40 letters cite both
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?38 letters cite both
- 21 CFR 820.50Purchasing controls35 letters cite both
- 21 CFR 820.75Process validation35 letters cite both
- 21 CFR 803.3How does FDA define the terms used in this part?34 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 820.100 that FDA posted most recently.
- DevicesView Next Medical Products Company, LLCClear Image Ultrasound Gel, Clear Image Sterile, non-sterile MediChoice Ultrasound Gel, and Clear Image SinglesIssuedAug 19, 2026PostedNov 3, 2026
- 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
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Counts include every citation in a letter, as the Letters filter does. How this database is built.