Search Results for cGMP violations

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FDA Warns 5 Drugmakers in China, Australia and Austria By Zachary Brennan - Published 18 January 2018

The five warning letters sent from the US Food and Drug Administration (FDA) in December and January deal with violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals and active pharmaceutical ingredients (APIs).

Categories: News, US, CDER, Active pharmaceutical ingredients, Compliance, Drugs, Manufacturing

Tags: warning letter, cGMP violations

FDA Warns Taiwanese Drug Manufacturer Over Significant cGMP Violations By Zachary Brennan - Published 07 June 2016

The US Food and Drug Administration (FDA) on Tuesday released a warning letter for Taiwanese drug and contract manufacturer Ko Da Pharmaceutical over four specific violations.

Categories: News, China, FDA, Compliance, Drugs, Government affairs, Manufacturing

Tags: Taiwan drug manufacturing, cGMP violations, FDA warning letters