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Manufacturing Compliance Updates In Brief From US FDA And EU

Executive Summary

Data integrity problems reemerged as a theme in seven recent drug GMP warning letters the US FDA sent to drug and active ingredient manufacturers at sites in South Korea, Australia, Taiwan, China, Ireland and France. Investigators also are seeing problems with inadequate testing of components and inattention to investigating batch failure. FDA issued a Form 483 report to Glenmark in India for inadequate cross-contamination controls, in the EU, the Spanish Agency of Medicines and Medical Devices withdrew one Spanish drug maker’s GMP certificate for multiple GMP violations.

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