Two Medical Device Companies, Orthopedic Alliance and Spinal Solutions, Receive FDA Warnings
3/29/2012 9:03:59 AM
During an inspection of your firm located in Murrieta, California, on July 20, 2011, through September 23, 2011, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures various orthopedic implant devices, including the SC Total Hip System and the SC Ceramic Ball Heads. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or they are intended to affect the structure or function of the body.