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Kesair Technologies lacked proper procedures to ensure that its air sanitation devices were designed in accordance with the FDA’s quality system regulation, the agency said, following an inspection of the firm’s Kennesaw, Georgia facility. Read More
Greiner Bio-One North America failed to complete validation testing and didn’t evaluate the effect of a manufacturing change, among other quality system failures, the FDA said in an April 16 warning letter. Read More
Luminex started using heater fixtures produced by a new component manufacturer in 2019; however, the change was implemented without an approved validation plan, according to a June 26 warning letter. Read More
FDA Commissioner Stephen Hahn said that the agency will resume domestic inspections this month using a new risk assessment system developed in response to the pandemic. Read More
MedTech Europe is urging the European Commission and EU member states to publish guidance that clarifies that notified bodies may conduct audits virtually in place of on-site audits during the COVID-19 pandemic for new devices and in vitro diagnostics. Read More
The FDA announced that it will delay enforcement of new requirements for unique device identification (UDI) on class I and unclassified medical devices until Sept. 24, 2022. Read More
In vitro diagnostics manufacturer Ramco Laboratories failed to validate all of its Class II IVDs, and it showed a history of lax record keeping, FDA investigators found in an inspection of its Stafford, Texas facility. Read More
ImmersiveTouch failed to validate its software for creating 3D virtual reality models from a patient’s computed tomography and magnetic resonance imaging data, the FDA found in an inspection of the company’s Chicago, Illinois facility. Read More