FDA 483 - Spinal Resources, Inc. - May 01, 2023

Spinal Resources, Inc. in Fort Lauderdale, FL, a specification developer of orthopedic medical devices, received a Form FDA 483 with seven observations. The inspection revealed significant deficiencies in their quality system, including failures in medical device reporting, acceptance activities, control of nonconforming product, complaint handling, management reviews, internal quality audits, and supplier controls. These issues indicate a broad lack of adherence to established procedures and regulatory requirements for medical device manufacturing.