JD Supra13d
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 ...
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 ...
Food Safety News11d
FDA issues warning letters to mushroom and produce importers for critical safety violations
Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a ...
Food Safety News1mon
FDA cracks down on food importers for major safety violations
Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a ...
Yahoo Finance24d
iRhythm secures 510(k) clearance for Zio device updates after FDA warning
The company stated in response to the Form 483 that it had “already taken ... progress when it came to remediating the FDA warning letters in an August 2024 earning call with analysts.
FDA Inspection Preparedness and Compliance Seminar (ONLINE EVENT: December 3-4, 2024/ON-DEMAND)
The "FDA Inspection Preparedness and Compliance" training has been added to ResearchAndMarkets.com's offering. This is a practical, hands-on two-day seminar designed to provide pharmaceutical, ...