Recipient: Spinal, USA
Product:Slimplicity Anterior Cervical Plate System, the Spinal USA Cement Restrictor and the Spinal USA Vertebral Body Replacement (VBR) System
This inspection revealed these devices are adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)], because the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations, Part 820 (21 CFR 820). Our investigators’ observations were noted on the Form FDA 483, List of Inspectional Observations (483) issued to you on June 6, 2007. These violations include, but are not limited to, the following:
You failed to maintain device master records (DMR) which include device specifications, including appropriate drawings, composition, formulation, component specifications, and software specifications [21 CFR 820.181(a)]. For example, although you contract with a company to manufacture your devices, you are required, as a manufacturer (specifications developer), to maintain DMR at your facility. You had no such records at your facility.
FDA New Orleans District Office