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 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 ...
Cdymax Pharma has been slapped with a warning letter from the FDA outlining two observations against the Bangalore, India-based API maker, both linked to testing shortfalls. The letter comes in ...
Zydus Lifesciences continues to be under intense scrutiny from the FDA, which hit the Indian drugmaker’s production facility in Jarod with a warning letter. Earlier this year, Zydus was slammed within ...
A website that markets ivermectin as a Covid-19 treatment has run afoul of the FDA. The agency issued a warning letter notifying the site that it is selling unapproved and misbranded products over the ...
Dexcom has received a warning letter from the FDA, after the agency uncovered issues during two inspections of the continuous glucose monitor maker’s facilities last year. In a filing with the SEC, ...
DexCom received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz.
The FDA sent a warning letter to Olympus this month describing a range of violations of federal requirements regarding manufacturing practices—marking the third such letter the medtech giant has ...
Dexcom, the local maker of continuous glucose monitors, received a warning letter from the Food and Drug Administration last week citing issues at two of its manufacturing facilities. The warning ...
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