JD Supra12d
Responding to Letters from FDA
There are several forms of communications FDA may send to signify an issue. FDA may send a company a notice of a violation in ...
Hosted on MSN11mon
FDA issues Cipla warning letter after thousands of complaints
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 ...
FDA posts warning letter sent to Owens & Minor related to August inspection
The FDA posted to its set a warning letter previously sent to Owens & Minor, Inc. dba American Contract Systems, following an inspection ...
Paulick Report on MSN5mon
FDA Issues Warning Letter To Toltrazuril Shop Over Sale Of EPM Medication
The U.S. Food and Drug Administration has issued a warning letter to the web-based business Toltrazuril Shop, informing the ...
medtechdive12d
FDA clears iRhythm’s second 510(k) in response to warning letter
However, the company said it will delay a submission for its next-generation Zio cardiac monitoring system until remediation ...
Food Safety News10d
FDA issues warning letters to mushroom and produce importers for critical safety violations
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 ...
MassDevice13d
FDA clears second set of changes to iRhythm Zio AT to resolve warning letter
Rhythm Technologies (Nasdaq:IRTC) announced that the FDA granted 510(k) clearance for Zio AT design modifications and ...
Food Safety News1mon
FDA cracks down on food importers for major safety violations
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 ...
Convenience Store News15d
FDA Warns 9 Retailers and 1 Manufacturer for Selling E-Cigarettes That Look Like Phones
The Food and Drug Administration on Wednesday warned nine online retailers and one manufacturer for selling or distributing ...
Convenience Store News13d
FDA Issues Warnings Over Vapor Products Resembling Smart Devices
The e-cigarettes include functions meant to appeal to youth, such as receiving text or call notifications, according to ...
oncnursingnews9d
Letter Warns Clinicians of Severe Infections With Pralsetinib for NSCLC
An ad-hoc analysis found a higher rate of severe and life-threatening infections in patients with RET-mutant lung cancer ...
Drugmaker shut down after black schmutz found in injectable weight-loss drug
The FDA became aware of the problem after a patient submitted a complaint to the regulator that a vial of semaglutide from ...