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A user facility adverse event was filed with the FDA, but no information was available in the service report concerning the medical impact on the patient, the agency said. Read More
The firm’s production processes were “not conducted, controlled and monitored to ensure that a device conforms to its specification,” the agency said. Read More
Environmental Tectonics: A litany of good manufacturing practices lapses related to documentation and validation resulted in a seven-item Form 483 for Environmental Tectonics following an inspection of its Southampton, Pennsylvania facility. Read More
The agency found a lack of evidence that customers used the devices solely for forensic and R&D purposes, as required by their instructions for use. Read More
Numerous documentation lapses were observed for corrective and preventive action procedures, including missing signatures and risk assessments of CAPA actions, the agency said. Read More
The FDA hit six devicemakers for a range of compliance failures observed during facility inspections, including lax acceptance procedures and missing records. Read More
Georgia’s Attorney General filed a complaint to temporarily stop Becton, Dickinson from operating its Covington medical device sterilization facility “in an unlawful manner.” Read More
Failure to validate equipment and to establish CAPA procedures were among the QMS failures discovered during an FDA inspection of contract manufacturer Custom Milling Center’s Golden, Colorado facility. Read More