From truckloads of torn documents to avian incursions in the production plant, Granules India’s recent manufacturing ...

iRhythm’s stock price has been volatile over the past five years, climbing as high as $274.21 and declining as low as $41.66. It was down 30 percent for 2024 and stood at $86.25 the day before the ...

The FDA said the problems “raise concerns about the quality and integrity of data generated by the labs,” which provide third-party testing and validation data services for device firms.

Last week, Zydus Lifesciences confirmed the receipt of an FDA warning letter at its Waghodia plant in Gujarat, India, marking ...

A drug production facility in Durham run by a Chinese company violated multiple safety regulations, according to the FDA. A ...

The FDA fired off Warning Letters to four companies — two in China and two in the U.S. — for marketing CPAP cleaning and sanitizing devices without clearance or approval.

Drug firm Zydus Lifesciences Ltd on Tuesday (September 3) provided some clarification regarding the receipt of a warning letter from the United States Food and Drug Administration (FDA) concerning its ...

Zydus Lifesciences Ltd. received a warning letter issued by the United States Food and Drug Administration with respect to its injectables manufacturing facility at Jarod near Vadodara. The warning ...

Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a ...

Salles has a purpose here. He is clearly not simply recording what happened; this is a film of political advocacy, warning against forgetting what tyranny did to the country and the stains it left ...

Your donation makes it possible for us to keep doing this important work, keeping you informed every step of the way to the November election The forecaster’s yellow warning for heavy showers ...