Failure to establish and maintain corrective and preventive action procedures, as required by 21 CFR 820.100(a). For example, there are no written Corrective and Preventive Action procedures.
Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, there are no written complaint procedures.
We reviewed your firm’s response and concluded it was not adequate. Although the response states complaint procedures are being established, there is no indication the software to be installed on the service technicians computers has been validated. In addition, a systemic corrective action is not addressed in your response.