FDA 483 - Ferno-Washington Inc - January 24, 2023

Ferno-Washington Inc, a medical device manufacturer in Wilmington, OH, was cited with six observations during an FDA inspection. The inspection revealed significant deficiencies in the firm's quality system, including inadequate procedures for corrective and preventive actions, process validation, supplier management, complaint handling, incoming product acceptance, and control of nonconforming product. These issues indicate a systemic lack of control over critical manufacturing and quality processes.