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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
Grace Fu Palma, founder and CEO of Boston-based China Med Device, a firm specializing in commercialization and funding for medtech companies entering China, explains how medtech companies can use a new guideline from the China FDA to help secure fast track approvals for innovative medical devices.Read More
Zimmer Biomet’s Warsaw, Ind., medical device facility was hit with a massive, 58-page Form 483 arising from an inspection carried out from September to November of 2016. Read More
Best Medical Canada landed a Form 483 for not establishing adequate complaint procedures or ensuring that its devices conformed to specifications. Read More