FDA 483 - Safeguard US Operating LLC - March 25, 2022

Safeguard US Operating LLC, a medical device manufacturer in Harrisburg, NC, received a Form FDA 483 citing significant quality system deficiencies. Observations included inadequate documentation of corrective and preventive actions, failure to properly investigate device complaints, and a lack of procedures for reworking nonconforming products. Additionally, the firm was cited for illegible labeling on its medical devices.