An FDA inspection involves more than the investigators who visit a manufacturing site. The reason for the inspection, the field team's findings and the agency's final classification are separate elements of a regulatory process. Understanding how these responsibilities are divided is essential for pharmaceutical manufacturers preparing for US market access or maintaining compliance. Article 1 in the “Mapping Inspection Systems” series. Following an overview of who may inspect a pharmaceutical...

The UK government has announced the establishment of the AI Biosecurity Lab (AIBL), a dedicated organisation intended to use advanced artificial intelligence (AI) to strengthen the detection and response to biological threats. The lab is backed by £100 million in government funding and up to £200 million in commitments from OpenAI and Anthropic, bringing the announced support for AIBL to up to £300 million. Announced by the Cabinet Office on...

Inspection responsibilities depend on a manufacturing site's location, activities, target markets and applicable regulatory procedures — not simply on the name of a medicines agency. Understanding these factors helps manufacturers identify which authorities may inspect their facilities and how existing inspection results may be used by other regulators. Consider a manufacturing site producing an active pharmaceutical ingredient (API) for customers in Europe, China and India, while finished products made from...

The European Committee on Organs, Tissues and Cells (CD-P-TO) of the Council of Europe, with Secretariat support from the European Directorate for the Quality of Medicines & HealthCare (EDQM), has published a position paper entitled “The regulatory approach to ex situ manipulation of human organs”. Adopted by the CD-P-TO on 8 October 2026 and published by the EDQM on 23 October 2026, the policy document proposes a European regulatory...

A September 2026 FDA Warning Letter to Baxter International identifies deficiencies in cross-contamination prevention, aseptic processing, environmental monitoring and quality investigations. The findings highlight why a documented Contamination Control Strategy (CCS) must be supported by evidence that manufacturing processes remain under control. The US Food and Drug Administration (FDA) issued a Warning Letter to Baxter International on 29 September 2026 following an inspection of Baxter Healthcare Corporation’s manufacturing facility in...