FDA 483 Citations for Training Under 21 CFR 820.25

"Procedures for training and identifying training needs have not been [adequately] established." FDA investigators cited 21 CFR 820.25(b) with that wording 50 times on system-generated Form FDA 483s in fiscal year 2025. Two related observations followed:

• "Personnel training is not documented," 820.25(b), 18 times

• "Personnel do not have the necessary [education] [background] [training] [experience] to perform their jobs," 820.25(a), 11 times

Training citations rarely appear alone. When an investigator finds a procedure that was not followed, a complaint that was not evaluated or a process that drifted, the next question is whether the people involved were trained. A weak training system turns one observation into two.

What the citations mean

Examples written after "Specifically" usually describe:

• No written training procedure, or one that does not say how training needs are identified

• Employees performing tasks, such as inspection or complaint review, with no record of training on the procedure

• Training records that list a course name but not the procedure revision trained on

• Procedures revised without retraining the people who use them

• No training on the consequences of improper job performance, or on defects people may encounter in their work

• Supervisors, contract workers or temporary staff left out of the training system

• No evaluation of whether training worked

What 21 CFR 820.25 required

Under the Quality System Regulation, each manufacturer had to have sufficient personnel with the necessary education, background, training and experience to assure that all activities required by Part 820 are correctly performed (820.25(a)).

Section 820.25(b) required procedures for identifying training needs and ensuring that all personnel are trained to adequately perform their assigned responsibilities. Training had to be documented. Personnel also had to be made aware of device defects that may occur from the improper performance of their specific jobs, and personnel who perform verification and validation activities had to be made aware of defects and errors they may encounter as part of their job functions.

What changed under QMSR

Since February 2, 2026, the Quality Management System Regulation incorporates ISO 13485:2016 by reference. Training requirements now come from clause 6.2, Human resources. Under clause 6.2, the organization must:

• Determine the necessary competence for personnel performing work affecting product quality

• Provide training or take other actions to achieve or maintain the necessary competence

• Evaluate the effectiveness of the actions taken

• Ensure personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives

• Maintain appropriate records of education, training, skills and experience

Clause 6.2 also requires the organization to document the process for establishing competence, providing needed training and ensuring awareness. Making people aware of the defects that improper work can cause, which the old regulation required by name, remains the most practical way to show that awareness.

The biggest practical change is effectiveness evaluation. A signature on a read-and-understand form shows that training occurred. It does not show that the person can perform the task. Expect investigators and auditors to ask how you know training worked.

How to respond to the 483

FDA generally considers responses received within 15 business days of the close of the inspection before deciding on further action. A credible response does more than retrain the people named in the observation.

Correct the immediate gap

Train the people named in the observation on the current procedure revision, document it and state the date. If untrained people performed quality-critical work, such as final inspection or complaint evaluation, assess that work. Review a sample of their decisions and say what you found.

Find the root cause

Common root causes include:

• No link between document control and training, so revisions do not trigger retraining

• No defined curriculum for each job, so no one knows what training is required

• Training managed by supervisors in spreadsheets that were not kept current

• New hires and contractors starting work before training is complete

Fix the training system

• A training procedure that defines how needs are identified, how training is delivered and how effectiveness is evaluated

• A training matrix listing each role and the procedures and skills it requires

• A rule that a revised procedure cannot become effective until affected people are trained, or a defined grace period with controls

• A requirement that no one performs a quality-critical task unsupervised until trained

• Effectiveness checks proportionate to risk, such as observed demonstrations, quizzes or review of the first records the person completes

• Training records that show the person, the document and revision, the date, the trainer and the effectiveness result

Look across the whole company

Compare every employee's training records to the matrix, including supervisors, engineers, contract workers and temporary staff. Report the number of gaps found and closed.

What a compliant training procedure contains

• Purpose, scope and responsibilities

• How competence requirements are set for each role

• New hire, cross-training and retraining triggers

• Training on procedure revisions

• Awareness of defects from improper job performance

• Methods for evaluating training effectiveness

• Qualification for special skills, such as soldering, welding, cleanroom gowning or inspection

• Training records and retention

• Periodic review of the training matrix

Common mistakes in training responses

• Retraining only the people the investigator named

• Treating a signed form as proof of competence

• Leaving document control and training disconnected, so the same gap returns

• Forgetting managers, engineers and contractors

• Committing to an effectiveness check but never defining what it is

Example: how one response section might read

This illustrates structure only; your response must describe your own facts.

Observation 3: Procedures for training have not been adequately established. Specifically, two final inspectors had no documented training on the current revision of the final inspection procedure.

Response:

• Correction: Both inspectors were trained on the current revision and passed an observed inspection on stated dates. Their final inspection records since the revision were reviewed, and no accepted nonconforming product was found.

• Root cause: Document control did not notify the training coordinator when procedures were revised.

• Corrective action: The document control procedure now requires a training impact assessment for each revision, and the electronic system blocks release until the training plan is assigned.

• Extended review: All 74 employees' records were compared to a new training matrix. Nineteen gaps were found and closed by a stated date.

• Verification: Quality will audit training records against the matrix quarterly for one year.

Frequently asked questions

Do we need a training procedure under QMSR?

Yes. ISO 13485 clause 6.2 requires the organization to document the process for establishing competence, providing needed training and ensuring awareness.

Is a read-and-understand form enough?

It can be enough for low-risk procedures, but it does not show competence for skilled or quality-critical tasks. Use observed demonstrations or tests where errors would affect product quality.

Do contract and temporary workers need training records?

Yes. Anyone who performs work affecting product quality must be competent, and you must be able to show it.

How A.P. Lyon documents help

A.P. Lyon's Training Procedure for ISO 13485 and FDA QMSR covers training needs, the training matrix, retraining triggers, effectiveness evaluation and records. Companies that also hold ISO 9001 can use the Dual-Standard Training Procedure. Training is also built into every ISO 13485 QMS package.

Documents are editable Word and Excel files and must be adapted to your organization. Your staff must be trained on them, and you remain responsible for showing competence.

Next steps

• Train the people named and assess the work they performed

• Build a training matrix and connect it to document control

• Add effectiveness checks for quality-critical tasks

• Respond within 15 business days with dates for each action

Related guides: Document Control Citations and CAPA Procedure Citations.

To build a complete set of procedures at a volume discount, use Build Your QMS. For help with a 483 response, see A.P. Lyon consulting services.

Not sure where your quality system stands? Take the free QMS gap check: about 20 questions, an instant report of your gaps by clause, and the procedures that close each one.