FDA GMP Nonconforming Product

Nonconforming Product control under FDA QMSR (ISO 13485:2016, Clause 8.3) requires procedures

for identifying and controlling non-confirming product.

FDA QMSRcGMP ComplianceISO 13485Since 2009

Control of Nonconforming Product - FDA QMSR (ISO 13485:2016)

The way medical device manufacturers must handle nonconforming products changed with the FDA’s transition to the Quality Management System Regulation (QMSR), which took effect on February 2, 2026, and replaced the former Quality System Regulation (QSR). Within the revised 21 CFR Part 820, the requirements once contained in Subpart I (§820.90) are now drawn from ISO 13485:2016, Clause 8.3 (Control of nonconforming product), brought into the regulation by reference through §820.10. Manufacturers distributing finished devices in the U.S. must control nonconforming products in line with ISO 13485:2016, together with the FDA-specific requirements that the QMSR adds.

Effective control of nonconforming product protects patients, supports recall readiness, and feeds directly into your CAPA system. LMG offers experienced QMS and CGMP consulting to help you establish, document, and maintain a compliant nonconformance process aligned with the QMSR and ISO 13485:2016. Our support covers:

Procedures for identifying and recording nonconforming product
Segregation and quarantine of nonconforming items to prevent unintended use
Disposition decisions — rework, scrap, concession/deviation, or return to vendor
Nonconformity investigation and root cause documentation
Integration with the CAPA system to address systemic or recurring issues

Beyond writing procedures, LMG provides end-to-end support for your transition to the Quality Management System Regulation. We begin with QMSR and ISO 13485:2016 gap assessments that compare your existing quality system against the new requirements and pinpoint exactly where action is needed. From there, our team assists with document and record development, drafting or revising the procedures, work instructions, and records that align your system with ISO 13485:2016. We also help design practical, audit-ready nonconformance and CAPA systems that work together to capture, investigate, and resolve quality issues. Finally, we prepare your team for both FDA inspections and notified-body audits, so you can demonstrate compliance with confidence. Whether you are moving from the legacy QSR or building a quality system from the ground up, LMG guides you through every step toward full compliance under the new Quality Management System Regulation.

Frequently Asked Questions

Common questions about FDA QMSR - Control of Non Confirming Products.

A product fails inspection — what does the QMSR actually require me to do with it?

The core steps haven’t changed, only the source. Under ISO 13485:2016 Clause 8.3 (which now sits inside 21 CFR Part 820), you must identify the nonconforming product, document the nonconformity, and make sure it can’t be used or shipped by mistake — typically through segregation or quarantine. You then decide its disposition and record the rationale. These are the same expectations the old §820.90 had, now expressed in ISO 13485 terms.

What disposition options are allowed, and do I have to justify them?

ISO 13485 recognizes the familiar routes: rework, scrap, return to vendor, or acceptance under concession (the QSR called this a deviation). Each decision has to be documented, including who authorized it and the justification — and for concessions, you generally need a record showing the relevant requirements were still met or appropriately addressed. The discipline around recordkeeping is, if anything, emphasized more clearly in the ISO 13485 language.

When does a nonconformance need to trigger CAPA?

Not every nonconformity becomes a CAPA, but a recurring or systemic one should. The link is built into the standard: nonconformance control (Clause 8.3) feeds the analysis-of-data and corrective-action processes. If you’re seeing the same defect repeatedly, or a single failure with significant patient-safety implications, that’s the signal to open a CAPA rather than just dispositioning the affected units. A well-designed system makes that escalation path explicit.