Imricor Medical Systems has announced another key milestone towards US regulatory approval for its devices with submission of ...

Imricor said six of these are the company’s products, which are undergoing the US Food and Drug Administration’s (FDA ... inspection and storage of raw materials, build procedures, process ...

Food safety testing is not only required by regulating bodies, it helps prevent contaminated product from getting out the ...

Who Should Attend: This seminar will provide an overview and in-depth snapshot of the entire process for preparing for and managing and FDA inspection and external regulatory inspections and for ...

Dublin, March 10, 2025 (GLOBE NEWSWIRE) -- The "FDA Inspection" training has been added to ResearchAndMarkets.com's offering. This seminar provides the fundamentals and the ground rules on how to ...

Dublin, March 10, 2025 (GLOBE NEWSWIRE) -- The "FDA Inspection" training has been added to ResearchAndMarkets.com's offering. This seminar provides the fundamentals and the ground rules on how to ...

FDA inspectors visited Dexcom’s facility in Mesa, Arizona, in June and its San Diego site in October and November. The inspections ... observations “related to process improvement and ...

In a regulatory filing, DexCom (DXCM) disclosed that on March 4, the company received a warning letter from the U.S. FDA following inspections ... 483 and is in the process of preparing a written ...

The U.S. Food and Drug Administration (U.S. FDA) has classified a warehouse of Aurobindo Pharma subsidiary in New Jersey, U.S. as Official Action Indicated (OAI) after an inspection it conducted.