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LumiQuick Diagnostics received an FDA warning letter after an investigator saw employees assembling a drugs of abuse test panel and an amphetamine test strip on the same table. Read More
A group of FDA task forces has recommended that the agency expand the amount of information it releases on inspections and enforcement, allowing the public to view a more detailed record of a company’s compliance history. Read More
MarCor Purification, a maker of water purification systems for the life sciences, has been warned by the FDA over CAPAs, investigations and complaint handling. Read More
Overall reports of adverse events in the UK declined over the past three years from 21,729 in 2011 to 14,819 in 2013, according to data published by the Medicines and Healthcare products Regulatory Agency. Read More
Irish devicemaker Covidien is voluntarily recalling certain lots of its Pipeline Embolization Device and Alligator Retrieval Device over concerns a coating applied to the delivery wire could detach from the devices. Read More
As the clock ticks down for high-risk devices to comply with the FDA’s unique device identifier rule, the first organization accredited to issue UDIs is offering devicemakers some advice. Read More
Medtronic Navigation of Louisville, Colo., received an FDA Form 483 for issues related to design validation, process validation, CAPAs, acceptance activities and nonconforming product. Read More