FDA Knew Drugmaker Had Poor Record. It Waited Four Years to Inspect One Factory
A Glenmark Pharmaceuticals factory in central India had been producing a generic drug linked to U.S. deaths. Three of the five factories where Glenmark made drugs for the U.S. market in recent years had been in trouble with federal regulators.
The Food and Drug Administration is cracking down on a generic drugmaker that was the subject of a ProPublica investigation last year, citing problems with safety tests that delayed the recall of a medicine linked to deaths in the U.S.
In December, ProPublica reported that a Glenmark Pharmaceuticals factory in central India was responsible for an outsized share of recalls for pills that didn’t dissolve properly and could harm American patients. Among the string of recalls, federal regulators had determined that more than 50 million potassium chloride extended-release capsules sold in the U.S. could be deadly. Yet, federal drug inspectors at that point hadn’t set foot in the Madhya Pradesh factory for more than four years, ProPublica found.
Seven weeks after that story was published, FDA inspectors showed up at the plant and found serious problems. Glenmark subsequently recalled an additional two dozen medicines made there and sold to U.S. patients.
Now the FDA has sent Glenmark a warning letter, a disciplinary tool the regulator uses to lay out significant violations of federal requirements and demand changes. If Glenmark fails to fix any of the problems outlined, the FDA warned, it may bar drugs made at the factory from entering the U.S.
What’s more, the FDA pointed out that the company had made similar serious mistakes at three other manufacturing sites and acknowledged that those factories had been the subject of previous warning letters from the agency since 2019. The problems at one were so severe that federal regulators blocked drugs made there from being imported to Americans. ProPublica’s December investigation highlighted this pattern, noting that three of the five factories where Glenmark made drugs for the U.S. market in recent years had been in trouble with federal regulators. Despite that track record, the FDA — backlogged from the pandemic — waited five years before sending its inspectors back to the Madhya Pradesh plant.
