FDA slaps China-based API makers with separate warning letters outlining quality, testing shortfalls
A pair of Chinese manufacturers with active pharmaceutical ingredients that were previously shipped to the U.S. | The FDA ...
FDA and DOJ also took action based on longstanding ... Maintaining a culture of compliance and a mature quality system is the best way to detect and mitigate medical product and food safety ...
Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, including a unique device RefluxStop ...
Medical Device Network on MSN13d
FDA grants 510(k) clearance to GE HealthCare’s updated ultrasound systems"FDA grants 510(k) clearance to GE HealthCare’s updated ultrasound systems" was originally created and published by Medical ...
20% of bioreactor runs at the Genzyme facility failed due to contamination or quality issues over 2.5 years. FDA identified 84 overdue deviation investigations, some exceeding 180 days ...
The commercial manufacturing example involves an AI-based visual analysis system that automates the assessment of a drug vial’s fill volume, where the volume is a critical quality attribute for ...
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