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FDA does not issue Form 483 observations because medical device manufacturers lack quality systems.
They issue them because physical control breaks down during execution.
Nearly every manufacturer has documented procedures for nonconforming products. NCRs are open. Holds are approved. Rework and disposition pathways are defined. On paper, these processes are complete.
Yet FDA inspection history shows that FDA nonconforming product control remains one of the most common sources of observations. Not because procedures are missing, but because product behavior on the factory floor does not consistently match documented intent.
Under QMSR, this gap becomes impossible to overlook. Inspectors no longer evaluate whether nonconforming product control was declared. They evaluate whether it was physically enforced from the moment a nonconformance occurred until final disposition.
What QMSR Changes About Nonconforming Product Control
Under both legacy QSR and ISO 13485, manufacturers are required to:
- Identify nonconforming product
- Prevent unintended use
- Segregate and control material
- Document disposition
- Holds
- Quarantine
- Rework
- Temporary staging
Under QMSR, it is no longer sufficient to show that a nonconformance was recorded in the QMS or that inventory status was updated in SAP. Inspectors expect evidence that the product remained physically controlled for the entire duration of the nonconformance.
This expectation exposes weaknesses that previously remained hidden behind system boundaries.
Why Control Appears Strong Inside Systems but Breaks Across Them
In most medical device manufacturing environments, nonconforming product control is distributed across multiple enterprise systems:
- QMS platforms manage NCRs, approvals, and disposition decisions
- MES platforms reflect production state and process routing
- ERP systems such as SAP track inventory status and ownership
- Spreadsheets or manual logs fill gaps for staging, overflow, or temporary locations
Each system may be accurate in isolation.
The failure does not occur inside these systems.
It occurs between them.
Nonconforming products rarely remain stationary. It moves from inspection to staging, staging to rework, rework back to QA, and often through temporary holding areas. At each transition, enforcement shifts away from system controls and toward human coordination.
At these handoff points, control depends on:
- Individuals correctly interpreting status across systems
- Physical space being available in approved locations
- Informal communication across shifts and departments
Under FDA inspection, these are not considered controls. They are assumptions.
This is why nonconforming products can appear fully controlled in SAP, MES, and QMS records while physically drifting outside governance on the factory floor.
The Failure Pattern FDA Inspectors Recognize Immediately
Consider a scenario that plays out in almost every manufacturing plant.
A batch fails inspection. QA opens an NCR in the QMS and places the product on hold. SAP inventory status is updated accordingly. The designated MRB or quarantine area is near capacity, so pallets are staged temporarily in a nearby location.
Shift change happens. Production pressure mounts. A supervisor, needing to clear a pathway, moves the pallets to a buffer zone. A new operator sees them, assumes they are staged for rework, and moves them closer to the line.
No procedure was intentionally violated. No record in SAP was changed. But physical control has completely failed.
When an FDA investigator asks, “Show me how you ensured this nonconforming product was contained,” the gap is exposed.
The system shows:
- NCR initiation and approval in the QMS
- Hold status reflected in SAP
- Rework routing visible in MES
Your reality cannot show:
- Where the product physically resided at each stage
- Whether access was restricted continuously
- How long the product remained outside approved areas
- Whether unauthorized movement occurred
This is not a documentation failure; your records were likely perfect.
It is a control enforcement failure. The system captured the administrative intent to contain the risk, but it lacked the operational mechanism to execute it. In the eyes of the FDA, a Quality System that cannot physically enforce its own decisions is not a system; it is merely a suggestion.
Why Temporary Locations Trigger FDA Scrutiny Under QMSR
FDA inspectors understand operational constraints. They also know that temporary locations are where control most often collapses.
Temporary staging areas are frequently:
- Poorly represented in ERP and MES models
- Not explicitly governed by QMS procedures
- Treated as short term but reused repeatedly
- Ambiguous in both physical control and system status
These failures frequently intersect with broader compliance gaps related to FDA approved medical equipment handling when nonconforming and conforming materials coexist.
Under QMSR, ambiguity is treated as a risk.
When nonconforming product is placed in a temporary location, inspectors do not ask why it was necessary. They ask whether control was maintained. If the organization cannot prove that access was restricted, movement was prevented, and status remained enforced, FDA assumes the product could have been inadvertently used.
This is why inspectors consistently focus on MRB areas, overflow racks, carts, totes, QA backlog zones, and mixed status storage. These locations expose whether nonconforming product control is enforced physically or relies on trust and intent.
They are not edge cases. They are deliberate inspection pressure points.
Why Status in SAP or MES Is Not Proof of Control
ERP and MES systems are designed to represent state. They record what a product is supposed to be.
FDA inspects behavior. They verify what actually happened on the factory floor.
This distinction becomes especially critical during audits tied to equipment qualification FDA expectations, where physical enforcement must align with documented system state.
A product marked “On Hold” in SAP or routed correctly in MES can still be physically moved, accessed, or staged alongside a conforming product as it passes through inspection, staging, rework, and temporary holding areas. When that happens, control has already been lost, even though system records remain correct.
Under QMSR, system status without physical enforcement is treated as an assumption, not evidence.
What Effective Nonconforming Product Control Looks Like Under QMSR
Manufacturers that perform well under QMSR approach control as an operational capability, not a documentation task.
Three characteristics consistently appear.
1. Physical Segregation Is Enforced Across Systems
Approved locations for nonconforming product are explicitly defined, consistently used, and aligned across QMS, MES, and ERP representations.
2. State and Location Remain Linked
Product status changes trigger location constraints, not just record updates. Where a product is allowed to be is governed as strictly as its documented state.
3. Deviations Are Detected When They Occur
Unauthorized movement is identified in real time, not discovered during audits through reconstruction.
How Location Data Bridges QMS, MES, and SAP
QMSR does not mandate specific technology. It mandates verifiable control.
In practice, many medical device manufacturers discover that manual enforcement of nonconforming product control does not scale across multiple shifts, constrained floor space, frequent handoffs, and complex rework loops. This is where gaps emerge between system records and physical reality.
Location data increasingly serves as the missing enforcement layer between enterprise systems:
- QMS defines status, intent, and authorization
- MES governs process flow and routing
- ERP systems such as SAP manage inventory state and ownership
- Location data verifies how products actually move and dwell on the factory floor
By continuously associating product status with physical location, manufacturers can demonstrate that documented controls were enforced, not just declared.
When product location is observable in real time:
- Segregation can be proven, not inferred
- Dwell time in controlled areas is measurable
- Unauthorized movement becomes immediately visible
- Containment can be verified without reconstruction
When this location evidence is paired with an operational digital representation of the facility, allowed behavior is enforced automatically rather than relying on assumptions, memory, or after-the-fact explanation.
This is not about replacing SAP, MES, or quality systems.
It is about making their control assumptions provable on the factory floor, where FDA inspections actually focus.
The KPIs Executives Should Be Asking For Under QMSR
Under QMSR, nonconforming product control shifts from a procedural exercise to an operational risk management responsibility.
Executives should focus on indicators that reveal whether physical control is consistently enforced, not just documented.
Key metrics include:
1. Loss of containment events
How often is nonconforming product detected outside approved or restricted locations?
2. Time to physical containment
How quickly is the product physically segregated after a nonconformance is identified?
3. Duration of exposure outside controlled areas
For how long did nonconforming products remain accessible or mobile before control was restored?
4. Manual control dependency
How frequently does containment rely on verbal confirmation, manual checks, or after-the-fact documentation?
5. Repeat containment failures
Do the same locations, workflows, or handoff points repeatedly generate loss of control events?
These indicators directly correlate with inspection outcomes. High values signal that control depends on trust and reconstruction rather than enforcement, increasing the likelihood of FDA observations under QMSR.
Why QMSR Will Surface These Gaps Faster Than Before
FDA inspectors are trained to follow product, not paperwork.
Under QMSR, inspections increasingly focus on how product actually moved, where it was staged, and whether physical control was continuously enforced across shifts and locations. Inspectors walk facilities, examine overflow areas, trace product movement, and ask for evidence that containment did not rely on assumption or reconstruction.
When control depends on memory, informal explanation, or system reconciliation after the fact, inspection confidence erodes quickly.
QMSR does not introduce new risks. It removes the buffer that previously allowed those risks to remain hidden.
QMSR takes effect on February 2, 2026. From that point forward, reconstruction will no longer be accepted as evidence of control. Manufacturers that cannot demonstrate physical containment as events occur will face findings not because controls were missing, but because enforcement could not be proven.
Why FDA 483s Will Target the Gaps Between Your Systems
The most serious FDA 483 observations under QMSR will not cite missing SOPs. They will cite failures to enforce control during execution.
Inspectors are not testing whether decisions were recorded correctly in QMS, ERP, or MES. They are testing whether those decisions were enforced as products moved across locations and handoffs.
This is where Location Intelligence becomes critical. When physical movement is continuously verified, control no longer depends on assumptions or reconstruction. Constraints defined in the quality system become enforceable on the factory floor.
LocaXion works with manufacturers to connect RTLS and Digital Twin capabilities to existing QMS, MES, and ERP environments, making physical control verifiable without replacing established systems.
Nonconforming product control does not fail because systems are missing. It fails because control breaks between systems.
With QMSR inspections beginning in February 2026, manufacturers that want to demonstrate control with confidence must address these gaps before inspection pressure exposes them.
Assess QMSR Readiness with LocaXion
FAQs on Non-conforming Products by FDA under QMSR
What changes under QMSR for managing nonconforming products?
Beginning February 2, 2026, QMSR does not introduce new requirements, but it raises the expectation for how control is demonstrated during inspections. FDA inspectors focus on whether containment was physically enforced across locations and handoffs, particularly for medical non-conforming products by FDA, rather than relying on documentation alone.
Why are FDA 483s commonly issued for nonconforming product control?
FDA 483s are issued when inspectors cannot verify that containment decisions were enforced during execution. Even when records are complete, a FDA nonconforming product that moves outside approved locations or remains accessible during holds, rework, or staging exposes a clear inspection gap.
Why do temporary locations increase FDA inspection risk?
Temporary staging areas often sit outside formal system governance and rely on informal coordination. Under QMSR, this creates risk because the control of non-conforming products must be continuously enforced, not inferred from intent or post-incident explanation.
Why do mixed-status areas draw increased FDA scrutiny?
When nonconforming and conforming materials coexist, the risk of inadvertent use becomes credible. FDA inspectors assess whether segregation and access controls are physically enforced to protect FDA approved medical equipment, especially as QMSR inspections intensify after February 2, 2026.
How does equipment qualification affect FDA inspections under QMSR?
Qualified equipment and validated processes establish capability, but they do not prove execution. During inspections, FDA evaluates whether real-world behavior aligns with documented controls, and gaps between system status and physical reality can lead to 483s tied to equipment qualification FDA expectations.