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The FDA announced it does not intend to enforce the requirement to use its unique device identifier system for labels on medical devices manufactured and labeled before Sept. 24, 2021. Read More
Poor supplier controls remain one of the top five FDA citations for device manufacturers, and with outsourcing continuing to grow, supplier networks can become a complicated web to manage. Read More
The FDA plans to unveil by Oct. 1 its own quality metrics for devicemakers based on three metrics from a pilot program conducted by Xavier Health and the Medical Device Innovation Consortium. Read More
Fluke Biomedical failed to properly select any of the suppliers for its CLEAR-Pb X-Ray shielding products, according to a five-observation Form 483. Read More
Pharmaceutical Innovations pled guilty to criminal and civil charges arising from its distribution of ultrasound gel contaminated with bacteria, according to the Department of Justice. Read More
General Medical Company, a maker of devices for excessive sweating, did not keep a record of verbal complaints and had problems with its complaint evaluations, the FDA found during an October 2015 inspection. Read More
Failure to validate equipment and computer software, and not establishing adequate procedures for implementing corrective and preventive actions, landed French devicemaker Eolane Vailhauques an FDA warning letter. Read More
FDA is warning healthcare providers of faulty filters used in Haemonetics’ Leukotrap RC System that are associated with higher than expected levels of leukocytes in transfused blood. Read More
The FDA is holding a public workshop Oct. 27 to Oct. 28 to discuss stakeholder input on refurbishing and reconditioning medical devices by third parties. Read More
Vancouver-based RS Medical was handed a 483 following a February inspection that found CAPA procedures and validation activities lacking. The company manufactures electrotherapy pain products. Read More
In an SEC filing last month, Zimmer Biomet had hinted at a warning letter but revealed little details about the exact nature of the deficiencies uncovered at the firm’s facility in Montreal, Canada. Read More