The FDA found that Sun Pharma, which produces generic drugs for U.S. consumers, failed to investigate the source of bacteria found in test vials or promptly deal with damaged equipment that had caused drugs to be contaminated with metal particles.
With deep job cuts at the FDA, inspectors say the ongoing strain could compromise policing an industry spread across more than 90 countries.
“Things will be missed, we are going to have a lot less safe drugs,” a former inspector said.
https://www.propublica.org/article/fda-cuts-drug-factory-inspections?utm_source=mastodon&utm_medium=social&utm_campaign=mastodon-post
The FDA allowed into the United States at least 150 drugs or their ingredients made at banned factories that were found to have mold, foul water, dirty labs or fraudulent testing protocols.
Key takeaways of our investigation:
https://www.propublica.org/article/fda-drug-safety-foreign-manufacturers-takeaways?utm_source=mastodon&utm_medium=social&utm_campaign=mastodon-post
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.
https://www.propublica.org/article/fda-tacrolimus-kidney-transplant-patient?utm_source=mastodon&utm_medium=social&utm_campaign=mastodon-post
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