Drugs

FDA Reports Gains in Drug Inspection Program

FDA says it continued to improve the speed and consistency of drug manufacturing oversight in fiscal year 2024, citing strong performance under an integrated inspection and facility evaluation framework that has been in place since 2017.

According to an FDA summary released this week, the agency met or exceeded key performance targets under its Concept of Operations agreement designed to better coordinate inspections and regulatory decision-making for human drug manufacturing facilities. The framework integrates activities between the agency’s drug review and field inspection functions to address increasing complexity in the global pharmaceutical supply chain, the agency says.

The initiative, launched jointly by CDER and the former Office of Regulatory Affairs, aims to improve efficiency, transparency, and alignment across FDA units involved in facility inspections and compliance actions tied to drug marketing applications. The Office of Regulatory Affairs was renamed the Office of Inspections and Investigations in fiscal year 2025.

For FY 2024, FDA reported that it issued 86% of final facility classification letters within 90 days of inspection closeout, slightly below the prior year’s 87% but well above levels seen earlier in the program. The agency also completed 88% of required regulatory actions for facilities classified as “official action indicated” within six months of inspection closeout, marking an improvement over FY 2023 and the highest level reported since tracking began.

Those benchmarks are central to the ConOps agreement and are intended to provide manufacturers with timely clarity on inspection outcomes, enabling faster corrective actions and more informed business decisions. The FDA said quicker communication of inspection results also supports continued access to high-quality medicines and may help accelerate the adoption of new manufacturing technologies and therapies.

Performance data spanning FY 2020 through FY 2024 show steady improvement overall, despite year-to-year variability. The percentage of final facility classification letters issued within 90 days rose from 78% in FY 2020 to the mid-80% range in recent years, while the share of regulatory actions completed within six months increased from 63% in FY 2020 to 88% in FY 2024.

FDA noted that the metrics apply specifically to domestic drug quality assurance inspections conducted under Compliance Program 7356.002 and do not include facilities evaluated through inspections performed by foreign regulators under mutual recognition agreements.

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