(ProPublica) – When Joe DeMayo’s donated kidney started to fail earlier than expected, he didn’t know that the drug he was taking could’ve left him vulnerable — and 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. (Read More)