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The FDA rapped Umicore Argentina for violations relating to its control procedures and equipment calibration, following a May inspection of the API manufacturer’s Buenos Aires facility. Read More
The FDA hit Rotterdam, Netherlands-based drugmaker Fagron for inadequate drug product storage and procedures for controlling recalled products at the firm’s Saint Paul, Minn., facility. Read More
An FDA inspection of Korean sterile OTC drug manufacturer Hanlim Pharm in January turned up multiple failures to follow procedures for preventing product contamination. Read More
The FDA slapped Xellia Pharmaceuticals with a Form 483 after finding quality and sterility shortcomings during a May inspection of its Copenhagen facility. Read More
The FDA flagged UBI Pharma for a slew of violations at its Hsinchu County, Taiwan, facility including inadequate environmental monitoring and sterility practices. Read More