FDA is required to periodic inspect medical device manufacturers for the compliance to the Good Manufacturing Practice (GMP).
FDA has notified your company that they will have an inspection at your site? Don't take the risk to receive a 483 or warning letter from FDA. Our experienced specialists analyse your existing quality managment system, identify the gaps and deviations, and take actions to achieve compliance to the 21 CFR 820 Quality Management Regulations. Due to their long experience with inspection- and audit situations our experts can prepare your staff for the upcomming event and support them during the inspection.
Benefit from our successful procedure for the preparation, execution, and analysis of the FDA inspection.
Please contact us for further details or a non-binding quotation.