Multimedia Medical Systems 3/18/97 Therapac-Plus and Compute-Rx-Plan Software 2. Failure to have approved, dated, and signed Device Master Records for Therpac-Plus Software and related Standard Operating Procedures (SOP) 100 through 133 [21 CFR 820.181]. 3. Failure to establish written procedures for the manufacturing and processing of the finished device [21 CFR 820.160]. There is no...Read More

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...Read More