There were unforgiveable shortcomings in management, which included critical information not reaching senior officials as ...
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, ...
FDA is under fire for missing its mandated food safety inspection goals every year since 2018 and for reducing funds for state and local food safety programs The Government Accountability Office ...
On Jan. 15, 2025, a warning letter was sent to Sanofi stating that FDA inspectors found irregularities with the facility's bioreactor, the vessel used to grow organisms and cells. According to the ...
The Food and Drug Administration has reclassified a recall of chocolate products to its most serious level. On Dec. 12, 2024, the Cal Yee Farm LLC of Suisun Valley, California, issued a recall for ...
including associated audit trails, for all 47 study participants enrolled in the AT-007-1002 trial at all clinical sites just two days after FDA preannounced its inspection of one of the clinical ...
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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