Automated Voice Systems 3/18/97 Environmental controller
1. Failure to control written manufacturing specifications and processing controls to assure that a device conforms to its original design or any approved changes in that design [21 CFR 820.100]. For example, our investigation determined that your firm failed to ensure that all changes made to your Mastervoice ECU powered environmental controller and the supporting justification for these changes were subject to controls as stringent as those applied to the original design specifications. Additionally, your firm has not established any specifications for the software components for the Mastervoice ECU powered environmental controller.