The FDA report at issue — Form 483 — is sent to a company's management after an investigator finds "any conditions that in their judgment" could be a violation of federal food-and-drug laws.

The FDA already contracts out a significant amount of inspection work on low-risk food categories, and it’s not the first time shifting food-safety enforcement responsibility to the states has ...

Since Glenmark’s potassium chloride recall in May, the company has told federal regulators it received reports of eight deaths in the U.S. of people who took the recalled capsules, FDA records show.

Ten years of FDA reports show a pattern of quality control issues at Emergent, long before cross-contamination led millions of potential COVID-19 vaccines to be ruined.

The FDA inspection report of the Sun Pharma factory in India warned of leaks that could allow dirty water into a sterile area where drugs were made. - Obtained by ProPublica.

But the GAO report showed that the FDA has struggled to meet its inspection targets for both domestic and foreign food facilities. Since 2018, it has failed to meet these targets, especially in ...

FDA must fix “inadequate” inspection and recall policies, report says A government watchdog said the FDA was not prepared to deal with a public health crisis such as the 2022 infant formula ...

FDA inspection operations face risk of further disruption amid mass HHS layoffs: report By Fraiser Kansteiner Apr 3, 2025 10:03am U.S. FDA Department of Health and Human Services layoffs job cuts ...

The report stated that 75,000 domestic food facilities were subject to FDA inspection under FSMA at the end of fiscal year 2023, with more than 17,000 of those facilities being high risk and ...

Although the FDA conducted 1,065 total drug plant inspections in fiscal 2023—a 40% increase compared to the same period in 2022—it was 36% below the 1,671 the agency conducted in 2019 prior to ...

Under FDA's own guidelines, drug factories that haven't been inspected in five or more years are considered a significant risk and are supposed to be prioritized for inspection.