21 CFR 820.75: Process validation
Required manufacturers to validate, with high assurance and documented approval, any process whose results can't be fully verified by later inspection or testing, then monitor and control it with qualified personnel and revalidate after changes or deviations.
Part 820, Quality System Regulation · Subpart G, Production and Process Controls
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 820.75, from the 483s we hold.
A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.Most used
A process whose results cannot be fully verified by subsequent inspection and test has not been validated according to established procedures.820.75(a)
Procedures for monitoring and control of process parameters for a validated process have not been adequately established.820.75(b)
Cited over time
483s citing 820.75, by yearMost citations in 2019. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2019.
Recent 483s citing 820.75
- Nanovis LLC · Columbia City, IndianaProcedures for validation of processes did not adeqi lately include statist! cal… Mar 19, 2026
- Raumedic Inc · Mills River, North CarolinaProcedures for validation of processes did not adeqi lately include approval of… Mar 13, 2026
- Marson Medical, Inc. · New JerseyA process whose results cannot be fully verified by subsequent inspection and test… Jan 16, 2026
- Sterigenics UK Limited · —A process whose results cannot be fully verified by subsequent inspection and test… Sep 25, 2025
- XL PRECISION TECHNOLOGIES LTD · —A process whose results cannot be fully verified by subsequent inspection and test… Aug 29, 2025
The regulation text
§ 820.75 Process validation. As published before it was replaced.
(a)Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, shall be documented.
(b)Each manufacturer shall establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met.
(1)Each manufacturer shall ensure that validated processes are performed by qualified individual(s).
(2)For validated processes, the monitoring and control methods and data, the date performed, and, where appropriate, the individual(s) performing the process or the major equipment used shall be documented.
(c)When changes or process deviations occur, the manufacturer shall review and evaluate the process and perform revalidation where appropriate. These activities shall be documented.
Questions
What does 21 CFR 820.75 require?
Required manufacturers to validate, with high assurance and documented approval, any process whose results can't be fully verified by later inspection or testing, then monitor and control it with qualified personnel and revalidate after changes or deviations.
How do FDA investigators word a 820.75 observation?
The most common opening is: “A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.”
Which sections are cited alongside 820.75?
In the same 483s, investigators most often also cite 820.100 (Corrective and preventive action), 820.30 (Design controls), 820.70 (Production and process controls), 820.90 (Nonconforming product).