FDA 483 - Republic Spine, LLC - September 26, 2025

Republic Spine, LLC received an FDA Form 483 following an inspection conducted from September 22-26, 2025. The observations indicate deficiencies in the company's quality system, specifically concerning complaint handling and finished device acceptance procedures.

The first observation highlighted that Republic Spine's procedures for receiving, reviewing, and evaluating complaints were inadequate. The company failed to adhere to its own Complaint Handling Procedure and Medical Device Risk Management policies, resulting in the underestimation of risk for seven complaints related to their Dark Star Pedicle Screw System and Interbody Lumbar TLIF devices. This non-compliance led to the submission of several Medical Device Reports.

The second observation identified inadequate procedures for finished device acceptance. The firm's Incoming Inspection and Testing and Statistical Techniques procedures were not adequately established or followed. This led to inconsistencies in how non-conforming materials were handled, including issues where devices with outdated engineering designs were accepted without corrective action or customer notification.

These observations, issued under the Federal Food, Drug and Cosmetic Act, require Republic Spine, LLC to conduct internal self-audits and implement corrective actions. The company has formally committed to correcting both noted observations.