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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
The Centers for Medicare & Medicaid Services imposed sanctions on Theranos following a litany of quality control failures for the blood testing company. Read More
The FDA has clarified expectations on unique device identifiers, which must appear in two forms on device labels and packages: an easily readable plain-text form and an automatic identification and data capture technology form. Read More
The EU’s new medical device regulations will have far-reaching implications for manufacturing and supply chain operations, and the least of which are increased roles and oversight from notified bodies that will directly impact quality management systems. Read More