There are several forms of communications FDA may send to signify an issue. FDA may send a company a notice of a violation in ...

The US Food and Drug Administration has issued a warning letter to Cipla after receiving thousands of complaints of defective products in the last couple of years. In the warning letter issued on ...

However, the company said it will delay a submission for its next-generation Zio cardiac monitoring system until remediation ...

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 ...

The FDA has added a new warning to drugs including Ozempic and Wegovy, cautioning that patients taking the drugs may be at a ...

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 ...

The FDA posted to its set a warning letter previously sent to Owens & Minor, Inc. dba American Contract Systems, following an inspection ...

Rhythm Technologies (Nasdaq:IRTC) announced that the FDA granted 510(k) clearance for Zio AT design modifications and ...

The warning letter issued by the US Food and Drug Administration (USFDA) relating to its injectables manufacturing facility at Jarod does not contain any data integrity-related violations ...

In a recent move, the FDA has added a warning to the labels of all GLP-1 receptor agonist drugs, commonly prescribed for weight loss and blood sugar control in diabetes. This new label states that ...