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, Food and Drug Administration 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.
A spokesperson for the company said in a written statement: “Glenmark is actively engaging with the U.S. FDA and has initiated corrective actions to address the agency’s observations. Patient safety, product quality and regulatory compliance are foundational to how we operate.”
