FDA 483 - Frantz Medical Development Ltd - June 27, 2023

Frantz Medical Development Ltd, a medical device manufacturer in Mentor, OH, was cited for significant deficiencies in its quality system. Observations include inadequate corrective and preventive action procedures and documentation, lack of established statistical techniques for process control, and missing procedures for nonconforming product rework. Additionally, the firm failed to fully document process revalidation and released products without completing necessary qualifications.