21 CFR 820.75
Process validation
21 CFR 820.75 is the regulation titled “Process validation” in 21 CFR Part 820, Quality System Regulation (before Feb 2, 2026). Since 2021, 51 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
- 51 since 2021
- Jan 1 to Oct 30, 2026
- 5 against 12 on the same dates in 2025
- Most often cited with
- 21 CFR 820.30, in 37 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 820.75 most often, as written in the letters.
- 4 lettersFailure to ensure that when 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…
- 2 lettersFailure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to…
- 2 lettersFailure to adequately ensure that when 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…
The regulation
Read the text of 21 CFR 820.75 (eCFR, as of Jun 1, 2025)
(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.
Text from eCFR as of Jun 1, 2025.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 820.75.
- 21 CFR 820.30Design controls37 letters cite both
- 21 CFR 820.100Corrective and preventive action35 letters cite both
- 21 CFR 820.198Complaint files25 letters cite both
- 21 CFR 820.90Nonconforming product23 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 807.81When a premarket notification submission is required21 letters cite both
- 21 CFR 820.80Receiving, in-process, and finished device acceptance18 letters cite both
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?17 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 820.75 that FDA posted most recently.
- 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
- DevicesView IsoTis OrthoBiologics, Inc.resorbable calcium salt bone void filler devices, branded under the Accell Family of products, to include the Accell Evo3cIssuedFeb 24, 2026PostedMar 24, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.