FDA 483 - Spinal Resources, Inc. - February 27, 2020

Spinal Resources, Inc., a medical device specification developer in Fort Lauderdale, FL, was cited with four observations during an FDA inspection. The firm failed to adequately establish procedures for design review, design verification, and design transfer, particularly concerning a T-25 Torx configuration design change. Additionally, the inspection revealed deficiencies in their corrective and preventive action procedures, specifically regarding thorough failure investigations and verification of effectiveness.