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 ...
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Raw milk to stem cells, Robert F. Kennedy Jr to rein in ‘inappropriate’ medical treatments
In 2005, a 5-year-old boy died after a doctor in western Pennsylvania tried to treat his autism with chelation. FDA sent ...
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 ...
Kennedy’s FDA wish list: Raw milk, stem cells, heavy metals
Robert F. Kennedy Jr., one of President-elect Donald Trump’s advisers on health, is taking aim at the agency’s oversight on ...
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 ...
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 ...
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 ...
Yahoo Finance6h
Intercept loses Ocaliva FDA full approval bid in rare liver disease
In its letter to Intercept, the FDA also said it was continuing to consider data from a post-marketing study called 747-302 ...
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 ...