Recipient: Pace Tech Inc.
Product: Stationary and portable patient monitors
Date: 4/29/05
Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures as required by 21 CFR 820 .75(a). Your firm fails to conduct adequate process validation in that soldering (baking) validation is not documented and there is no validation of software used in the complaint repair system to document previous repairs to devices.
Your response dated March 18, 2005 addressing FDA 483, Item #12A & B is inadequate because there is no evidence of a validation protocol or actions that have been taken to date for both your soldering process and changes made to software.
FDA District: Florida District Office
