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Germany’s Biotronik received a warning letter for inadequate process validation procedures, supplier selection procedures, and other violations. Read More
Korea-based Neo Vision received a warning letter for failing to establish proper design controls, monitor production processes, maintain device history records, and other violations. Read More
The FDA slapped medical device manufacturer XZeal Technologies with a Form 483, citing issues with reporting procedures and design validation. Read More
The FDA sent Canada-based Savaria Concord Lifts a warning letter citing twelve violations regarding corrective and preventive actions (CAPAs), complaint evaluations, software validation, and other areas. Read More
Rapid Release Technologies received a warning letter for failing to apply for premarket approval (PMA) or an investigational device exemption (IDE) for a massage device. Read More
Germany’s Biotronik received a warning letter for inadequate process validation procedures, supplier selection procedures, and other violations. Read More
FDA inspectors observed various problems at a Narishige medical device facility in Tokyo, including inadequate design control procedures and other violations. Read More
Advanced Breath Diagnostics was hit with a Form 483 citing 11 observations related to corrective and preventive actions (CAPA), rework and reevaluation activities, acceptance procedures, and other areas. Read More