21 CFR 820.90 - Nonconforming Product (QMSR)

What it says

Procedures must be established to control product that does not conform to specified requirements, including identification, documentation, evaluation, segregation where practical, and disposition, with responsibility for review and disposition of nonconforming product clearly defined.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Nonconforming product control requires genuine physical or systematic segregation where practical, preventing nonconforming material from being inadvertently used or shipped while its disposition is pending.
• Disposition decisions, use as is, rework, repair, or scrap, must be documented with the rationale behind the specific decision made, not just the decision itself.
• This provision connects directly to CAPA under 820.100, since nonconformity trends are one of the required data sources CAPA analysis must draw from.

What FDA inspectors look for

• Whether nonconforming product is genuinely segregated or otherwise controlled to prevent inadvertent use, not just documented as nonconforming while remaining accessible for use.
• Whether disposition decisions include documented rationale specific to the nonconformity, rather than a generic or repeated justification applied across different situations.
• Whether nonconformity data is fed into the CAPA system for trend analysis, not handled as an isolated, one-off event each time.

Related regulations