by Debbie Cenziper and Megan Rose

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Joe DeMayo always knew his healthy years could end abruptly, bound to the lifespan of a transplanted kidney about the size of a small fist. But as the father of a toddler, he had hoped to have more time.

When he was 33, his wife had donated her kidney to him, a milestone that changed the course of DeMayo’s life. The relentless fatigue, nose bleeds and itchy skin brought on by his own poorly functioning kidneys vanished, and he felt good enough to leave home in Philadelphia for a new beginning in the foothills of northern California.

Over long afternoons, DeMayo would hike in the mountains with his wife and their black-and-white mutt, Fausto. When his son was born, he’d imagined himself coaching baseball games, clad in Phillies gear.

But his donated kidney started to fail in early 2023, much earlier than expected. The decline came as a surprise to DeMayo, who had been faithfully taking his medications, including tacrolimus, an essential immunosuppression drug that helps stave off organ rejection.

DeMayo didn’t know at the time that the capsules he swallowed twice a day precisely 12 hours apart could have left him vulnerable — or that one of the most formidable drug regulators in the world may have failed to protect him.

As he grew weaker, his kidney unable to cleanse his body of excess fluid and waste, investigators from the Food and Drug Administration headed to western India to inspect the factory that manufactured DeMayo’s tacrolimus and other generic drugs for American consumers.

It was at least the eighth time since 2015 that the FDA had been there, and each of those visits had uncovered problems in the way the drugs were made, government records show.

During the inspection in the spring of 2023, investigators discovered the Intas Pharmaceuticals factory had, among other things, manipulated drug-testing records to cover up the presence of particulate matter — which could include glass, fiber or other contaminants — in the company’s drugs.

Unaware of the inspection, DeMayo continued taking his tacrolimus capsules. He fought exhaustion and struggled to hold onto his job behind a deli counter.

“Daddy needs........

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