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 ...
JD Supra11d
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 ...
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 ...
medtechdive11d
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 News9d
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 ...
MassDevice12d
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 ...
MedPage Today19d
FDA Warns Companies Over Products Made With Amniotic Fluid
These warning letters are the latest in a series of FDA efforts to crack down on companies selling birth-tissue-derived ...
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 ...
FDA lifts hold on North Carolina drug factory one year after maggots found
The U.S. Food and Drug Administration has lifted a clinical hold on three cell therapies being developed by CARsgen ...
AZ Central29d
Opinion: Trips Ahoy isn't Chips Ahoy, but cannabis-infused snack packaging looks close
But other companies didn’t get the message. The FTC and FDA have sent another batch of warning letters to five companies selling products containing THC in packaging that resembles popular snacks and ...
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 ...