FDA 483 - Topcon Healthcare Inc. - March 14, 2025

An FDA inspection of Topcon Healthcare Inc. in Oakland, NJ, a medical device manufacturer, revealed significant deficiencies across its quality system. Observations included late Medical Device Report submissions, inadequate design validation for software, and insufficient risk analysis. The firm also failed to adequately establish procedures for corrective and preventive actions, maintain complaint files, ensure auditor independence, and conduct proper management reviews.