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 ...
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, ...
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US FDA Inspection on Rise: Indian Pharma and Medical Devices Manufacturers Strengthen GMP ComplianceIt's important to note that the FDA's inspection activities are gradually returning to pre-pandemic levels, with a 40% increase in total inspections from fiscal year 2024-25. To achieve audit ...
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 ...
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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