The "FDA Inspections: From Site Preparation to Response" training has been added to ResearchAndMarkets.com's offering. This is a practical, hands-on two-day seminar designed to provide pharmaceutical, ...
There were unforgiveable shortcomings in management, which included critical information not reaching senior officials as ...
On Jan. 15, 2025, a warning letter was sent to Sanofi stating that FDA inspectors found irregularities with the facility's ...
Two top clinicians have been disciplined amid growing concern that Kaiser’s system for monitoring research safety and ethics ...
The FDA issued a warning letter to Sanofi regarding significant manufacturing violations at its Genzyme Corporation Facility in Framingham, Mass. The letter, dated Dec. 16, 2024, and amended Jan. 15, ...
Pharma, biopharma, and medical device makers should watch out for these perennial problems, which include inadequate ...
Cipla on Monday (January 20) announced that the United States Food and Drug Administration conducted an inspection of its ...
As is common following an inspection, FDA issued observations of conditions that could be improved at one of our facilities," Taylor Farms said in a statement. The company "immediately took steps ...
including self-inspections for manufacturing and the famous FDA Mock Inspection or Mock Audit. It will explain how to prepare for an inspection, how to handle a scheduled or non-scheduled ...
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