Preparing for an FDA Inspection
Preparing for an FDA inspection is not a DIY project. While many companies have competent internal resources, the stress of an impending inspection causes many daily functions to suffer. We, at GMP Scientific, can make it easy for you by managing your overall inspection readiness plan with well-proven strategies, and support your organization with a detailed execution plan.
We do it all, from planning and developing detailed timelines, establishing milestones, identifying and reducing risks, communicating with your management, training and coaching your personnel, and augmenting your resources with qualified consultants.
These planning and preparation exercises will strengthen your organizational confidence in facing the FDA inspection.
Responding to FDA 483 observations & Warning Letter
Responding to FDA 483 observations or a Warning Letter causes an extraordinary burden on a firm’s Quality System and organizational resources. We, at GMP Scientific, can provide you with expert guidance, in a timely professional manner that will enable you to meet FDA expectations.
We do it all, from planning your response and remediation strategy to preparing a detailed execution plan, and support your overall project until you have an acceptance from the FDA. This will improve the overall confidence and improve your organizational competence in responding to the FDA.