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 for screws and other medical devices has not been validated.
For example, during our inspection, your firm stated that a written protocol for software validation does not exist and records of such validation activities do not exist.
FDA District: Los Angeles District Office
