Today on FDA’s website, Elizabeth Miller, PharmD, Associate Commissioner for Inspections and Investigations, and Lowell Zeta, JD, Acting Chief of Staff and Deputy Commissioner for Strategic Initiatives, penned an article (here) titled Investing in FDA’s Inspectional Enterprise. The article outlined FDA’s view of the evolving nature of the FDA inspections program and outlined several objectives of the program including a transparency component regarding how FDA plans, coordinates, and executes inspections across the agency.
They note they “are advancing that transformation through a more aligned, risk-informed, and transparent approach to inspectional operations that is already taking shape across the FDA”.
The Agency will concentrate on training new staff assuring “career development, cross-functional opportunities, and organizational transparency — we are building an agency that attracts, retains, and empowers the talent necessary to fulfill our public health and public safety obligations for the long term”.
There is no question that the Agency has a lot on its plate with today’s complex global supply chains dealing with new manufacturing technologies as well as data integrity expectations.
The article goes on to say that FDA in FY 2025 alone conducted over 17,000 domestic and foreign inspections, reviewed about 74 million import lines, and collected over 25,000 samples.
To help meet these challenges in an efficient manner, “the FDA recently established the Inspectional Affairs Council, or IAC, as a cross-agency governance body focused on inspectional matters” which “coordinates strategic decision-making and enhances alignment between OII and the Centers on inspectional activities”. The overall goal is to inspect, evaluate, reach a decision in a timely manner and coordinate those decisions in cooperations with the review Office in the appropriate Centers.
The article also notes that FDA is increasing unannounced inspections which provides a more effective tool for assessing current manufacturing quality. The article also notes that: “In India, the FDA’s foreign office went from 47% unannounced inspections in FY 2025 (139 total inspections) to 87% unannounced in FY 2026 year-to-date (76 total inspections). For the China Office, the share of unannounced inspections rose from 19% in FY 2025 (192 total inspections) to 61% in FY 2026 year-to-date (114 total inspections)”.
The Agency is examining how it uses its resources and recognizes the need for a highly trained inspectorate and with program enhancements and a continued human centric approach they hope to strengthen “public trust and ensures that the FDA continues to meet the demands of a complex and rapidly evolving public health landscape”.
