Theqmnweeklybulletin

March 24, 2017

Vol. 9 No. 12

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Implant Dental Tech. Warned About Contamination

The FDA hit Guangdong, China-based Implant Dental Technology with a warning letter citing equipment contamination, production deficiencies, and other violations. Read More

Manufacturers Must Give France’s ANSM More Product Info

A recently implemented decree by France’s Agency for the Safety of Health Products (ANSM) requires manufactures of Class III and implantable medical devices to provide new summaries of product characteristics when a device is put into service. Read More

Arch Pharmalabs Cited for Water Quality, Computer Problems

Arch Pharmalabs received a Form 483 from the FDA listing numerous problems including water quality, documentation and computer system issues. Read More

EMA’s GCP Working Group Outlines Inspection Priorities, New Guidances

The European Medicines Agency’s working group on good clinical practices and inspections outlined its goals for 2017, including plans to prioritize certain site inspections. Read More