Recipient: The Byran Co. Inc.Product: Implantable surgical spine screws and rods Date: 2/3/05 Software validation activities for your automated computer system used as part of production have not been performed or documented for its intended use according to an established protocol, as required by 21 CFR 820.70(i). Specifically, the software used for setting the specifications...Read More

http://www.fda.gov/cdrh/osel/programareas/software.htmlRead More