21 CFR 820.90
Nonconforming product
21 CFR 820.90 is the regulation titled “Nonconforming product” in 21 CFR Part 820, Quality System Regulation (before Feb 2, 2026). Since 2021, 43 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
- 43 since 2021
- Jan 1 to Oct 30, 2026
- 5 against 13 on the same dates in 2025
- Most often cited with
- 21 CFR 820.100, in 33 letters
- Closed out
- 16% of these letters have a published close-out
Letters citing it, by year issued
All are medical device letters. 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 820.90 most often, as written in the letters.
- 3 lettersFailure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a)
- 2 lettersFailure to adequately establish and maintain procedures to control product that does not conform to specified requirements, including the identification, documentation, evaluation, segregation, and disposition of…
- 2 lettersFailure to adequately establish procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). Specifically,
The regulation
Read the text of 21 CFR 820.90 (eCFR, as of Jun 1, 2025)
(a) Control of nonconforming product. Each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements. The procedures shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product. The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation shall be documented.
(b) Nonconformity review and disposition. (1) Each manufacturer shall establish and maintain procedures that define the responsibility for review and the authority for the disposition of nonconforming product. The procedures shall set forth the review and disposition process. Disposition of nonconforming product shall be documented. Documentation shall include the justification for use of nonconforming product and the signature of the individual(s) authorizing the use.
(2) Each manufacturer shall establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications. Rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product, shall be documented in the DHR.
Text from eCFR as of Jun 1, 2025.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 820.90.
- 21 CFR 820.100Corrective and preventive action33 letters cite both
- 21 CFR 820.30Design controls29 letters cite both
- 21 CFR 820.198Complaint files26 letters cite both
- 21 CFR 820.75Process validation23 letters cite both
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?21 letters cite both
- 21 CFR 820.50Purchasing controls19 letters cite both
- 21 CFR 807.81When a premarket notification submission is required18 letters cite both
- 21 CFR 820.80Receiving, in-process, and finished device acceptance17 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 820.90 that FDA posted most recently.
- DevicesView Peter Schiff Enterprisescardiac electrode pads and AC cardiac fibrillatorsIssuedAug 26, 2026PostedOct 27, 2026
- DevicesView Olympus Medical Systems CorporationSurgical and endotherapy devices including clips, sphincterotomes, cystoscopes, bronchoscopes, and insufflators.IssuedOct 7, 2026PostedOct 20, 2026
- DevicesView Physitemp Instruments, LLCClinical Electronic Thermometers (TH-5; TH-5/AOP; TH-8; TH-8/AOP), Clinical Temperature Monitoring Probes (OT-1; ESO-1; RET-1; SST-1;…IssuedNov 12, 2025PostedMar 31, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.