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# FDA Aims to Modernize Inspection Program
- URL: https://www.fdaweb.com/fda-aims-to-modernize-inspection-program/
- Published: 2026-08-03T12:00:00.000Z
- Updated: 2026-09-14T13:44:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161562

FDA says it is undertaking a broad modernization of its inspection program, including expanded use of risk-based oversight, greater reliance on remote evaluation tools, and a sharp increase in unannounced inspections of foreign manufacturing facilities, according to a new post by senior agency officials.

FDA associate commissioner for inspections and investigations **Elizabeth Miller** and acting chief of staff and deputy commissioner for strategic initiatives **Lowell Zeta** say the agency is seeking to make its inspection enterprise more "aligned, risk-informed, and transparent" while investing in workforce development and improving the efficiency of its oversight activities.

The [officials' post](https://www.fda.gov/news-events/fda-voices/investing-fdas-inspectional-enterprise?utm%5Fmedium=email&utm%5Fsource=govdelivery) notes the initiative comes as FDA faces increasingly complex global supply chains, evolving manufacturing technologies and growing demands on its inspection workforce. “The FDA’s inspectional responsibilities have grown more complex over time,” they say. “Global supply chains span dozens of countries. Manufacturing technologies continue to evolve. Data integrity expectations are increasing, particularly for facilities that rely heavily on electronic systems and distributed operations.” During fiscal 2025, the agency conducted more than 17,000 domestic and international inspections, reviewed nearly 75 million import lines and collected more than 25,000 product samples.

As part of the overhaul, FDA has established an Inspectional Affairs Council, a cross-agency governance body intended to improve coordination among the agency's product centers and inspection offices. The council will oversee inspection strategy, workforce planning and operational improvements, while formalizing processes through a [staff manual guide](https://www.fda.gov/media/192339/download?attachment&ref=fdaweb.com) issued earlier this year.

The agency also is refining its inspection strategy by matching inspection frequency to a facility's risk profile, manufacturing complexity and compliance history rather than relying on uniform inspection schedules. “Right-sizing means aligning inspectional effort with risk, complexity, and public health need,” the officials say. “It recognizes that a facility with stable operations and documented voluntary compliance history may justify a lower inspectional priority relative to a facility with complex manufacturing processes, novel technologies, or known compliance concerns.” FDA is developing operating agreements that more clearly define responsibilities between its inspection staff, product centers and foreign offices while streamlining inspection planning and reporting.

In addition, FDA says it plans to expand the use of alternative oversight tools, including records requests, remote interactive evaluations and inspection reports from trusted foreign regulators operating under mutual recognition agreements. It contends that these approaches can help increase inspection capacity while allowing inspectors to focus on higher-risk facilities.

The post also highlights FDA's effort to increase parity between oversight of domestic and foreign manufacturers through more unannounced overseas inspections. In India, unannounced inspections increased from 47% of 139 inspections in fiscal 2025 to 87% of 76 inspections conducted so far in fiscal 2026\. In China, the percentage of unannounced inspections rose from 19% of 192 inspections in fiscal 2025 to 61% of 114 inspections year to date in fiscal 2026\. The agency says the shift is intended to provide a more accurate assessment of manufacturing quality at facilities producing products for the U.S. market.

FDA notes it is also expanding investigator training, standardized onboarding and cross-functional career development to strengthen its inspection workforce. Agency officials say the modernization effort is designed to improve regulatory consistency for industry, better target inspection resources to higher-risk activities and enhance public confidence in FDA's oversight of regulated products.