FDA 483 - Spinal Solutions, LLC - September 11, 2012

The FDA Form 483 details observations from an inspection of a facility that designs, develops, kits, sells, and distributes finished medical devices, including the Lancer Pedicle Screw System, spinal fixation systems, and interbody fusion devices. These products are supplied by other companies and distributed via Surgical Sales Representatives/independent contractors.

Several violations were noted: 1. **Design Control:** Procedures for design control have not been established. This includes the absence of defined, documented, and implemented procedures for a design and development plan, design history file, design inputs, design output, design review, design verification, design validation (including risk analysis), and design transfer. No procedures for design change exist. 2. **Device History Records (DHR):** Procedures for DHRs are lacking. Specifically, there is no procedure to document the storage and filling process of consigned kits with components returned by independent contractors. Records are unavailable for initial product kitting, quantity consumed at each site, quantity distributed, and reoccupancy activities. 3. **Purchasing Controls:** Procedures to ensure purchased products and services conform to specified requirements are inadequate. Existing agreements with suppliers (Companies redacted and redacted) and independent contractors do not describe quality responsibilities, including complaints, Medical Device Reports, DHRs, Design History Files, labels/labeling, product design, and changes. No agreement exists with Company redacted. 4. **Labeling Control:** Procedures to control labeling activities