Repeat FDA violations keep showing up across drug, biologic, and device manufacturers because problems are systemic, including weak quality systems, sloppy data integrity, poor documentation, inadequate CAPA and training, and failures in environmental control and equipment qualification. These issues aren’t new, but they keep recurring because organizations often treat compliance as merely paperwork, rather than […]
The FDA’s new internal generative-AI assistant ELSA (Enterprise Language Support Assistant) is an agency-wide tool launched in June 2025 to help reviewers, investigators, and scientists read, summarize, and prioritize large volumes of regulatory and safety data faster. The agency reports use across clinical protocol review, adverse-event summarization, label comparison, and inspection targeting. Early rollout shows
Between 2024 and 2025, the FDA shifted from pandemic-era stop–start inspection tactics to a sustained, more aggressive, data-driven, and technology-enabled oversight posture for foreign facilities. Key changes include increased foreign inspection coverage (with FY2024 showing a marked rise), formalization and expansion of remote regulatory tools (RRAs), pilot-to-policy rollout of unannounced foreign inspections, and the use
From 2024–2025 FDA inspections the single biggest theme in documentation failures is data integrity and poor recordkeeping, including missing, incomplete, or altered records that undermine confidence in test results and release decisions. Other common documentation failures include incomplete batch records, inadequate deviation and CAPA documentation, poor electronic records controls (Part 11 gaps), weak supplier documentation,
Weak CAPA (Corrective and Preventive Action) and investigation systems are among the most frequent and serious inspection findings in life sciences and pharmaceutical manufacturing. The root causes are usually not single errors but recurring organizational and process failures: poor root-cause analysis, weak procedures, superficial investigations (often labeled “human error”), ineffective verification of corrective actions, inadequate
The FDA announced an expanded program of unannounced inspections at foreign manufacturing sites in May 2025. The move is driven by (1) growing reliance on overseas manufacturing for drugs, biologics, and food; (2) persistent data-integrity and cGMP problems found more often in foreign inspections; (3) the need to prevent concealment of violations that advanced notice
The FDA has released 76 new Product-Specific Guidances (PSGs), including 64 for drugs without approved generics and 29 for complex products, strengthening the pathway for high-quality generic drug development. These PSGs outline the FDA’s current expectations for bioequivalence, study design, and data requirements, helping manufacturers reduce development risk, accelerate ANDA approvals, and improve access to
Global manufacturers must treat the U.S. FDA’s Import Alert framework as a dynamic, operational risk-control mechanism, not just a customs nuisance. Import Alerts can trigger automatic “detention without physical examination” (DWPE), stop shipments at the border, and force expensive corrective paths. To stay resilient, manufacturers should understand how alerts are structured (DWPE, red/yellow/green lists), monitor
Continuous Supplier Monitoring (CSM) has become one of the most important capabilities for life sciences and pharmaceutical manufacturers today. Modern supply chains are global, complex, and heavily regulated. A single supplier failure, whether related to APIs, excipients, packaging, or cold-chain logistics, can disrupt production, delay batch release, impact regulatory inspections, or even put patient safety
The FDA’s expectations for SaMD (Software as a Medical Device) submissions have moved decisively toward a total product life cycle (TPLC) approach that emphasizes transparent device description, rigorous risk and performance characterization, comprehensive data management and bias mitigation plans, human factors evidence, and post-market monitoring and change control, especially for AI/ML-enabled SaMD. Sponsors must show
