by Patricia Callahan

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The Food and Drug Administration has found problems at an Indian factory that makes generic drugs for American patients, including one medication that was manufactured there and has been linked to at least eight deaths, federal records show.

The agency inspected the factory after a ProPublica investigation in December found that the plant, operated by Glenmark Pharmaceuticals, was responsible for an outsized share of recalls for pills that didn’t dissolve properly and could harm people. Among the string of recalls, the FDA had determined last year that more than 50 million potassium chloride extended-release capsules had the potential to kill U.S. patients.

Still, ProPublica found, the FDA had not sent inspectors to the factory in Madhya Pradesh, India, since before the COVID-19 pandemic.

When FDA inspectors went to the Glenmark plant last month — five years after the agency’s prior inspection — they discovered problems with cleaning and testing that they said could affect medicines that were shipped to American consumers.

In a report detailing their findings, the inspectors wrote that Glenmark failed to resolve why some medicines weren’t dissolving properly, and they raised concerns about the factory’s manufacturing processes.

“Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product,” the inspectors wrote.

The FDA redacted large swaths of the inspection report, making it impossible to tell whether inspectors uncovered the reason for the pills not dissolving correctly or which Glenmark drugs sitting in American medicine cabinets were potentially at risk of........

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