21 CFR 820.90: Nonconforming product
Required manufacturers to have procedures for identifying, documenting, evaluating, segregating, and dispositioning nonconforming product, defining review authority, documenting justification and signatures for use, and controlling rework with retesting recorded in the DHR.
Part 820, Quality System Regulation · Subpart I, Nonconforming Product
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 820.90, from the 483s we hold.
Procedures have not been adequately established to control product that does not conform to specified requirements.Most used
Products that do not conform to specifications are not adequately controlled.820.90(a)
Procedures have not been established to control product that does not conform to specified requirements.820.90(a)
Cited over time
483s citing 820.90, 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 820.90
- CSA Medical, Inc · Lexington, MassachusettsProcedures to define the controls and related responsibilities and authorities for… Mar 23, 2026
- Amigo Mobility International, Inc. · —Nonconforming product was not adequately evaluated to determine the need for an… Feb 5, 2026
- Marson Medical, Inc. · New JerseyProcedures have not been adequately established to control product that does not… Jan 16, 2026
- Encore Laboratory · —Products that do not conform to specifications are not adequately controlled… Jan 9, 2026
- Solomon Park Research Laboratories, Inc. · Burien, WashingtonProcedures that define the responsibility for review and the authority for the… Jan 8, 2026
The regulation text
§ 820.90 Nonconforming product. As published before it was replaced.
(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.
Questions
What does 21 CFR 820.90 require?
Required manufacturers to have procedures for identifying, documenting, evaluating, segregating, and dispositioning nonconforming product, defining review authority, documenting justification and signatures for use, and controlling rework with retesting recorded in the DHR.
How do FDA investigators word a 820.90 observation?
The most common opening is: “Procedures have not been adequately established to control product that does not conform to specified requirements.”
Which sections are cited alongside 820.90?
In the same 483s, investigators most often also cite 820.100 (Corrective and preventive action), 820.198 (Complaint files), 820.75 (Process validation), 820.30 (Design controls).