Available from Boyce Consulting Inc.
Boyce Consulting has helped numerous companies comply with FDA regulations and compliance programs, especially in critical situations involving FDA-483 observations, Warning Letters, recalls, correction and removals and FDA inspections. We are experts at developing systemic corrective action plans and helping you to implement them to ensure you satisfy FDA regulations.
However, we can also help you use a proactive approach before FDA finds any problems. We can audit your facility and/or contractors. We can help you correct any problems before FDA finds them to ensure you are fully compliant and your processes are user friendly and effective.
However, If you determine you are going to have an FDA audit, we can help you during the audit to help it runs more smoothly for you.