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The FDA handed U.S. Infusion a Form 483 for violations including failure to notify the agency within 30 days after learning of a device malfunction that could result in patient injury or death. Read More
U.S. FDA officials visiting India laid out a new approach to facility inspections that would reward Indian devicemakers whose quality management systems exceed the minimum. Read More
Indian devicemakers, together with governmental and nongovernmental partners, have formed a steering committee to push a self-certification proposal for manufacturing best practices. The aim is to ensure the quality of Indian devices and eliminate sales of substandard products. Read More
The EU was set to sign on as a full observer to the International Medical Device Regulators Forum’s single audit program when the group met in Tokyo in late March, according to an FDA official familiar with the talks. Read More
Devicemakers soon will start feeling the impact of the Center for Devices and Radiological Health’s inspectorate overhaul following the addition of quality-driven metrics and pre- and postapproval confirmation of controls audits, a center official says. Read More
Devicemakers can help to facilitate facility inspections — and improve their inspection experience — by engaging in constructive conversations with agency investigators, a U.S. FDA official says. Read More
Customed, a Puerto Rican maker of convenience packs for surgical procedures, received a U.S. FDA warning letter for unacceptable warehouse conditions and other GMP issues.
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MedOne Surgical, a Sarasota, Fla., devicemaker, received an FDA Form 483 for failures related to complaint records, in-process acceptance and other procedures. Read More
The FDA has handed Cenorin a warning letter for not reporting modifications to its Medical Device Cleaning and HLD Washer/Pasteurizer Model 610. Read More