FDA Warning Letters Are Telling Us Something: Reactive Compliance Is No Longer Enough

TL;DR

• Recent FDA warning letters expose failures in proactive, risk-led controls — not just missing procedures.

• QMSR (Feb 2026) hard-wires ISO 13485 and enterprise-wide risk management into compliance expectations.

• Predictive compliance is rapidly becoming a regulatory and commercial differentiator.

As we move into 2026, FDA warning letters are becoming less about what went wrong and more about why organisations failed to see it coming. The signals are increasingly consistent across cGMP inspections. Issues are rarely novel or unforeseeable; they are systemic, visible in the data, and, in the worst cases, unmanaged until inspectors intervene.

Recent enforcement actions against cGMP facilities reinforce this pattern. Deficiencies point to the absence of active, predictive controls rather than isolated procedural failures. The message from regulators is clear: documentation alone is no longer enough if it does not drive action.

This shift is not accidental. It’s a signal of the industry regulators’ direction and reflects how regulators, such as the FDA, are preparing the Medical Device industry for a new quality era under the Quality Management System Regulation (QMSR), which takes effect on 6th February 2026.

Enforcement Behaviour Is Already Changing

Although QMSR is effective but not yet enforced, the enforcement posture has already evolved. Warning letters increasingly highlight weak risk escalation, poor linkage between complaints and CAPAs, and insufficient oversight of suppliers and production controls. The emphasis is moving from the presence of processes to the effectiveness of insight.

In practice, the FDA is asking a harder question: does your quality system surface risk early, or does it simply record failure after the fact? This is the fault line between reactive compliance and predictive compliance.

Mandatory ISO 13485 Alignment Raises the Baseline

QMSR formally retires the FDA’s historic, US-centric Quality System Regulation in favour of alignment with ISO 13485:2016. This is more than a structural update. It resets the compliance baseline to a global, risk-based standard.

ISO 13485 assumes continuous risk awareness, management accountability, and traceability between data, decisions, and outcomes. For global manufacturers, this removes duplication. It also removes the comfort of “local compliance” as a defence.

Risk Management Is Now Embedded Everywhere

Under 21 CFR Part 820, risk management often lived primarily in design controls. Under QMSR, risk-based decision-making must be embedded across the entire QMS, including purchasing, training, supplier management, production, and complaint handling.

Risk is no longer a static artefact. It becomes an operating signal that inspectors will expect to see actively informing priorities and actions. Organisations that still treat risk as a document, rather than a management input, will struggle.

Internal Audits Become Inspection Evidence

One of the most underestimated QMSR changes is the removal of the Management Audit Exception. Internal audits and management review records are no longer shielded from FDA inspection.

This fundamentally changes the role of internal quality data. Audit findings are no longer a private mechanism for self-correction; they are regulatory evidence. The focus shifts to how early issues are surfaced, escalated, and addressed by leadership.

For executives, this demands a cultural shift. Predictive compliance requires audit data to act as an early-warning system, not a retrospective justification.

A Common Language for Global Compliance

QMSR also adopts ISO terminology, replacing familiar concepts such as the Device Master Record (DMR) and Design History File (DHF) with the Medical Device File (MDF). While the technical content remains similar, the implications are operational.

In a harmonised regulatory environment, inconsistent language creates friction and risk. Shared structures and shared understanding become essential for global inspection readiness. Language, in this context, becomes part of compliance infrastructure.

Inspections Will Target Integration, Not Checklists

The retirement of the Quality System Inspection Technique (QSIT) signals another clear shift. The FDA’s forthcoming inspection model will focus on how effectively ISO 13485 is integrated with FDA-specific obligations such as MDR and UDI.

Inspectors will probe how risk signals flow across systems, how trends are detected, and how decisions are prioritised. Fragmented, manual, and retrospective approaches will be exposed quickly. Real-time visibility will increasingly separate inspection-ready organisations from the rest.

Why Predictive Compliance Is Becoming a Business Advantage

Taken together, these changes redefine compliance from a defensive cost centre into a strategic capability. Predictive compliance protects revenue, reduces disruption, and accelerates regulatory confidence by identifying issues before they escalate.

This is the shift GxP Group is focused on enabling: transforming fragmented regulatory and quality data into predictive, decision-grade intelligence. In a post-2026 environment, organisations will be divided between those that document compliance, and those that understand it in motion.

2026 is not just a deadline. It is a dividing line. Contact us today to discuss how we can help you through this transition.