Company: Neuro Control Corp.
Date: 4/9/01
Product: NeuroControl Freehand System
Also, at the time of the meeting your firm was using a procedure entitled, “Return Inspection Procedure for the Freehand Backup Implantable Components”. As we stated in our meeting with your firm, this procedure appears to involve electronic record. The recent FDA inspection revealed that your firm is also utilizing electronic record keeping (a new Field Reports Database) in your CAPA procedure. In your March 31, 2001 letter of response to the FDA 483 it was indicated that the Field Reports Database is currently being validated and is scheduled for full implementation by April 16, 2001. However, your response did not outline your firm’s global action plan to address all record keeping issues at your firm.
FDA District: Cincinnati District
