Capnia Inc – FDA 483, May 7, 2026

An FDA inspection of Capnia, Inc. in Foster City, CA, a medical device manufacturer, revealed significant deficiencies across its quality management system. The firm was cited for inadequate documentation of design control procedures, including design output, traceability, and verification testing. Additionally, the inspection found failures in applying a risk-based approach to complaint handling and nonconforming product, as well as incorrect risk management calculations and issues with product identification and batch size documentation.