A Jubilant HollisterStier facility, which focuses on liquid sterile products including injectables, was issued an FDA warning letter. (Stock Photo ) Jubilant HollisterStier, a CDMO unit of India’s ...

Lupin is having continued difficulty solving problems at its factory in Tarapur, India, and has received another warning letter from the FDA, the generics producer revealed in a regulatory filing.

Whoop made changes to its blood pressure insights feature that satisfied the FDA’s requirements for wellness devices.

CHELMSFORD — Medical device manufacturer Zoll was given a warning letter by the U.S. Food and Drug Administration for what the FDA said were violations of quality systems and medical device reporting ...

The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not posted for public view until weeks or months after ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months ...

All the small things, true care, truth brings,” sang Blink-182 and, in the world of medical devices, it is the small things that can bring ...

Wavi, a neurological medtech company, was recently hit with a warning letter from FDA accusing the company of selling an unauthorized device to help diagnose patients with potential neurological ...

FDA Closes Case: The FDA ended its warning letter against Whoop on June 24, 2026, after the company updated its blood pressure feature to comply with wellness device standards. Interface Adjustments: ...

What is an FDA Warning Letter? Did you receive an FDA warning letter? If so, then there are critical steps you can take today to prepare and to be able to respond promptly to the warning letter. The ...