FDA 483 - Signature Orthopedics Pty Limited - July 05, 2018

Signature Orthopedics Pty Limited, a medical device manufacturer in Sydney, Australia, received a Form FDA-483 with three observations. The inspection revealed deficiencies in establishing adequate procedures for corrective and preventive actions, evaluating the impact of failed test equipment, and conducting management reviews. These issues indicate a need for improved quality system controls.