FDA warning letters highlight recurring patterns, systemic gaps, and evolving priorities that medical device manufacturers ...

Documents obtained by ProPublica offer a rare glimpse into discussions between the global drugmaker Sun Pharma and the FDA, ...

Dangerous products are marketed as “kratom extract” or “enhanced kratom” and often disguised as candies, gummies and even ice ...

Drugmaker Sun Pharma pledged sweeping reforms after years of persistent safety violations at its flagship manufacturing plant in Halol, India, but failed to follow through, according to FDA documents ...

FDA’s Warning Letter to WHOOP, a manufacturer of cutting-edge, wellness wearable tech, has sent shivers through an industry enjoying ...

FDA Warning letters can be harbinger of formal civil and criminal investigations. If your business receives such a notice of non-compliance from the FDA, you should immediately contact an ...

The Food and Drug Administration (FDA) sent warning letters to some health care companies – including CVS Health and Walgreens Boots Alliance – for marketing unapproved eye products. The ...

Patricia Callahan ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. The Food and Drug Administration is ...

The Food and Drug Administration (FDA) sent warning letters to three infant formula manufacturers over violations of federal safety regulations, the agency announced Wednesday. ByHeart, Mead ...

The number of warning letters the FDA sent to medical device-makers fell by almost 90 percent between 2015 and 2019, and it could be because the FDA is too focused on pleasing the device industry ...

The FDA has issued a warning to consumers not to purchase and to immediately stop use of Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops because of bacterial and fungal contamination.