We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » Eminent 483 Notes Validation, Lack of Documented Procedures
Eminent 483 Notes Validation, Lack of Documented Procedures
September 2, 2010
Eminent Spine received a Form 483 after the FDA found its cleaning instructions for intervertebral body fusion systems were not validated to show the procedure is capable of removing contaminants, such as body fluids, from the instruments.