Staff cuts and lost experience strain FDA oversight of overseas drug factories.
The Food and Drug Administration (FDA) is facing one of its most difficult chapters as recent staff cuts ripple through an already strained system. Behind the scenes, experienced inspectors who once traveled the world to check drug factories now say they are overwhelmed. Many support workers were laid off—people who handled logistics like travel paperwork, translators, and local arrangements—making it harder to plan and carry out inspections. Even though some of those roles have been refilled, others remain vacant. Without this foundation, inspectors are stretched thin, leading to fewer inspections and slower follow-up on known risks.
Some of the world’s most common medications, including chemotherapy drugs and antibiotics, are made overseas, often in factories located in India and China. Inspectors have flagged serious safety issues in some of these places for years—dirty tools, bad ingredients, and faked reports. In one recent case, a drug for transplant patients was found to dissolve too quickly, putting people at risk. It had come from a factory with past violations, which had already been barred from selling in the United States.
A recent round of layoffs reduced the FDA workforce by more than 3,000 people. Though leaders claimed these changes would not affect inspections, many in the agency say that’s not true. They’ve seen delays, confusion, and even basic day-to-day issues pile up. One employee had trouble getting into her own office because there was no one left to help with building access. Another couldn’t replace a broken mouse due to missing tech staff.
The job of an inspector is not easy. Some spend months away from home, traveling through difficult conditions to visit manufacturing sites. With fewer hands on deck, the stress is climbing. Those left behind often feel unsupported, and some are considering leaving as well. Between 2022 and 2024, the agency lost as many inspectors as it hired. Roughly one in three currently working does not have enough experience to inspect factories overseas on their own. According to federal watchdogs, the agency needs at least 100 to 200 more seasoned inspectors just to stay on top of its responsibilities.
Agency officials have said they are trying new tools to help manage the situation. A new system powered by artificial intelligence was recently launched to spot high-risk factories, and the FDA has also announced it will increase unannounced inspections. But many believe these steps won’t be enough to fill the growing gaps. Some say it’s like expecting doctors to treat patients without nurses, lab techs, or medical assistants.
The loss of long-serving investigators only adds to the pressure. Their experience often helped uncover hidden problems that newer staff may not recognize. Without this knowledge base, it’s harder to detect the patterns that suggest deeper issues. Former leaders in the agency have warned that even if inspectors themselves were not technically laid off, their work is still being undercut by the lack of support.
There is also concern that the current administration has not offered enough public detail about which cuts will be reversed and how the agency will recover. Several former FDA officials believe the recent changes put drug safety at risk, especially for lower-cost generics that many hospitals rely on. In 2023, the FDA received more than one million reports of issues with medications, and without proper oversight, more may go unnoticed.
For those inside the agency still trying to do their jobs, the situation has become increasingly difficult. Some say they are shocked at the lack of backup and the rising burden. One inspector described feeling like chaos was being added to an already fragile system. As the agency continues to deal with the fallout, questions remain about how many problems will be missed—and what it could mean for patients who trust the pills they take
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FDA Cuts Will Limit Scrutiny of Troubled Foreign Drug Factories, Inspectors Say
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