Pharmaceutical regulatory inspection and enforcement activity has intensified sharply across the FDA, MHRA, and EMA over the past year, with warning letters, foreign site inspections, and data integrity findings all trending upward at the same time. For QA, GxP, and compliance teams – and for the contract manufacturers and vendors they rely on – these shifts carry direct operational implications, from where inspection resources are concentrated to which violation categories now carry the greatest enforcement risk. This article consolidates the current picture across all three major regulators into a single reference.
FDA’s Center for Drug Evaluation and Research (CDER) issued 303 warning letters to drug and biologics manufacturers in fiscal year 2025, a 59% increase from 190 in FY 2024.¹ Several factors are driving the increase: a return to full-scale inspection activity following the pandemic-era slowdown, a significant staff restructuring in spring 2025 that affected approximately 3,500 FDA employees (with some subsequently reinstated), and an intensified focus on data integrity and quality system failures across both domestic and foreign facilities.²
This is not the picture of an agency in retreat. CDER approved 46 novel drugs in 2025, evidence that core regulatory functions remain fully operational even as enforcement activity accelerates.³ For QA teams, the practical takeaway is that inspection and enforcement pressure has increased without any corresponding reduction in regulatory throughput – which means both readiness and responsiveness now matter more than ever.
The GLP-1 space became the single biggest enforcement focus of 2025-2026. FDA issued more than 58 warning letters addressing false or misleading claims about compounded GLP-1 products – including compounded semaglutide and tirzepatide – through late 2025 and early 2026, and followed with 30 further warning letters to telehealth companies in a single coordinated action in June 2026.⁴
In September 2025, the FDA also introduced a “Green List” import alert targeting active pharmaceutical ingredient (API) sources for GLP-1 products, restricting entry for foreign API manufacturers that have not demonstrated GMP compliance.⁵ Together, these actions show how quickly enforcement attention can pivot to a single product category – a pattern directly relevant to any organization with exposure to compounding, telehealth-linked supply, or GLP-1 API sourcing.
More than 62% of FDA drug quality inspections in FY 2024 targeted foreign manufacturing sites, reflecting the increasingly global footprint of the pharmaceutical supply chain.⁶ Combined with the Green List initiative and a growing list of import alerts covering non-compliant foreign facilities, the picture is one of intensifying supply chain enforcement.⁷ For organizations that manufacture or source APIs overseas – or that rely on contract manufacturers who do – regulatory exposure is meaningfully higher than for purely domestic operations, and due diligence on supplier GMP status has become a frontline compliance activity rather than a periodic check.
The MHRA completed 353 GMP inspections in 2024/25, demonstrating sustained inspection capacity despite resourcing pressures felt across regulators globally. The dominant theme in MHRA findings continues to be data integrity: between 2016 and 2023, data integrity failures accounted for nearly 40% of all critical and major GMP deficiencies, the large majority involving electronic systems.⁸
In practice, this means MHRA scrutiny extends well beyond the accuracy of the underlying science to how laboratories and manufacturing sites document, track, and manage records throughout their lifecycle. The MHRA reserves the right to perform risk-based supervision through either on-site or distant assessments, and outcomes for non-compliant sites can include restriction or withdrawal of GMP certification – consequences that halt UK market access immediately.
An emerging issue worth flagging rather than treating as an established trend: the MHRA and the Defective Medicines Report Centre (DMRC) are actively monitoring an increase in reports of Bacillus contamination in aseptic facilities, and are liaising directly with NHS and Specialist Pharmacy Services on the issue.⁹
No firm causal link has been established across these reports, but Bacillus species are notable for producing spores resistant to standard alcohol-based cleaning methods, and previous instances of this type of contamination have been linked to inadequate sanitization of raw materials and consumables used in manufacturing.
Manufacturers of sterile products – and any organization auditing a sterile manufacturing partner – should treat this as a prompt to review environmental monitoring programs and sporicidal cleaning protocols now, ahead of any formal regulatory update.
In December 2025, the European Parliament and the Council of the European Union reached political agreement on a comprehensive reform of EU pharmaceutical legislation – the most significant overhaul of the framework in over 20 years.¹⁰ Formal adoption is expected by summer 2026, with a multi-year transition period to follow.
The reform covers four headline changes:
The enforcement angle for compliance teams is less about any single provision and more about the transition period itself. As the reform moves toward formal adoption and national implementation, companies operating in the EU should expect a period of genuine compliance uncertainty, and should monitor EMA guidance closely as the detailed implementing rules are published through 2026 and beyond.
In January 2026, the FDA and EMA jointly published ten guiding principles for good AI practice in drug development, covering AI use across the full medicines lifecycle – from nonclinical and clinical development through manufacturing and post-market safety surveillance.¹¹ Other regulators, including China’s NMPA and India’s CDSCO, alongside the MHRA, are separately moving toward adaptive pathways and rolling review models. It is worth noting that the FDA/EMA principles are guidance, not binding regulation – but they signal clearly where formal rulemaking is heading.
The second cross-regulator theme is a shift toward continuous data transparency rather than point-in-time submissions. Regulators increasingly expect real-time or near-real-time visibility into quality and safety data, rather than periodic snapshots delivered at inspection or submission milestones. This is both a compliance challenge – systems need genuine real-time reporting capability, not retrofitted dashboards – and a strategic opportunity: organizations that invest early in continuous data transparency will be better positioned as this becomes the baseline regulatory expectation rather than the exception.
The table below consolidates the headline metrics from this piece into a single reference – worth bookmarking ahead of your next compliance briefing or leadership update.
FDA’s Center for Drug Evaluation and Research issued 303 warning letters to drug and biologics manufacturers in fiscal year 2025, a 59% increase over the 190 issued in FY 2024 – the highest volume in recent years.
Recent FDA enforcement has concentrated on quality unit oversight failures, inadequate testing and identity verification of incoming materials, weak investigation practices, and data integrity gaps – particularly at foreign manufacturing sites.
Data integrity remains the MHRA’s dominant enforcement theme, alongside sustained risk-based inspection activity and emerging monitoring of Bacillus contamination risk in aseptic manufacturing – see the sections above for the current detail on each.
The EU reached political agreement in December 2025 on the most significant pharmaceutical legislation reform in over 20 years, covering antimicrobial development incentives, market exclusivity, centralized procedures, and shortage management. Formal adoption is expected by summer 2026, followed by a multi-year transition period.
Enforcement trends are moving quickly, and the practical implications for any single organization depend heavily on its specific risk profile – manufacturing footprint, product categories, and supplier network among them. The Infodesk inspection and enforcement intelligence solution tracks FDA, MHRA, EMA, and other global regulators in one place, turning fast-moving enforcement activity into intelligence that QA, GxP, and compliance teams can act on directly. Inspection and Enforcement Intelligence (I&E Intelligence) pulls every inspection record and enforcement action into one place across seven health authorities, then turns it into the profiles, briefs, and reports your team needs to prepare. The Infodesk I&E Intelligence solution is the only solution to turn I&E intelligence into action within a single platform that also monitors other enterprise intelligence streams and integrates with a workflow solution for immediate outcomes.
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