Quality Electrodynamics, LLC..
Product: cois used in conjunction with MRI scanners .
Failure to document validation activities, as required by 21 CFR 820.75(a). Specifically,
The setting (temperature and line speed) used during the validation studies for the reflow oven, which is part of the SMT (Surface Mount Technology) line, to determine the optimum settings were not documented. Therefore, it is unknown if you are currently operating the reflow oven within your validated parameters.
Your response dated March 26, 2015 cannot be assessed at this time. The response states that you have placed all 176 oven reflow profiles under the change control process and revised your ?Validation of Processes and Software? procedure, SOP 021; and training is ongoing. You are also working with an SMT (Surface Mount Technology) expert to aid in monitoring the process capability and control of the SMT line. Additionally, you have ordered new process monitoring equipment. Please provide an update on the progress of these corrective actions.
FDA District Office: Cincinnati District