21 CFR 820.25: Personnel
Required manufacturers to employ enough qualified personnel, establish procedures to identify training needs, train and document training for all staff, and make them aware of defects that could result from improperly performed work.
Part 820, Quality System Regulation · Subpart B, Quality System Requirements
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 820.25, from the 483s we hold.
Procedures for training and identifying training needs have not been adequately established.Most used
Personnel training is not documented.820.25(b)
Procedures for training and identifying training needs have not been established.820.25(b)
Cited over time
483s citing 820.25, 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 820.25
- Amigo Mobility International, Inc. · —Process(es) for establishing competence, providing needed training and ensuring… Feb 5, 2026
- Marson Medical, Inc. · New JerseyProcedures for training and identifying training needs have not been adequately… Jan 16, 2026
- Tactical Medical Systems Thermal · Oviedo, FloridaProcedures for training and identifying training needs have not been established… Aug 8, 2025
- MAVIDON MEDICAL PRODUCTS · Flat Rock, North CarolinaEMPtOYEE(S) SIGNATURE Procedures for training and identifying training needs have… Aug 5, 2025
- ATZ Manufacturing · Marshall, MinnesotaProcedures for training and identifying training needs have not been established… Jul 24, 2025
The regulation text
§ 820.25 Personnel. As published before it was replaced.
(a)General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.
(b)Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.
(1)As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs.
(2)Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.
Questions
What does 21 CFR 820.25 require?
Required manufacturers to employ enough qualified personnel, establish procedures to identify training needs, train and document training for all staff, and make them aware of defects that could result from improperly performed work.
How do FDA investigators word a 820.25 observation?
The most common opening is: “Procedures for training and identifying training needs have not been adequately established.”
Which sections are cited alongside 820.25?
In the same 483s, investigators most often also cite 820.100 (Corrective and preventive action), 820.198 (Complaint files), 820.50 (Purchasing controls), 820.22 (Quality audit).