EVOLUTION DEVICES, INC – FDA 483, Apr 15, 2026

EVOLUTION DEVICES, INC, a medical device specification developer in San Francisco, CA, was cited for multiple quality system deficiencies during an FDA inspection. The firm failed to adequately manage complaints, conduct timely corrective actions, update risk management files, control nonconforming products at contract manufacturers, and ensure proper monitoring equipment procedures. Additionally, the company did not perform internal audits at planned intervals or adequately evaluate critical suppliers prior to manufacturing, indicating systemic issues in maintaining a compliant quality system.