You depend on your suppliers to provide quality products, but each supplier represents a risk. If you are registered to 21 CFR 820, there are strict FDA guidelines in place governing expectations for supplier controls.
Medpoint offers several services to help you prepare for an FDA audit and avoid the time and expense of responding to FDA findings that drain resources and cause added expense.
Preparation: With so much at stake, you can’t afford to face an FDA audit unprepared. Medpoint offers FDA mock audits to help prepare you for a visit before it ever occurs. Our experienced auditors will help train your team how to prepare for and support an FDA audit, while reviewing your documentation to ensure it is prepared and ready to withstand the rigors of FDA inspectors.
Continual Improvement: If there are self-identified potential gaps in your process, but you are unsure how to close them, let Medpoint assist you. We will come along side you to review where you are, and what steps can be taken to improve your processes and procedures. Get the peace of mind that comes with knowing you are prepared for an FDA audit.
Audit Response: If you have already had an FDA audit and received observations, or even a warning letter or consent decree, you are not alone. In 2014, the FDA issued more than 3,700 observations for findings against 21 CFR 820 and 54 warning letters. As unfortunate at is to receive a finding from the FDA, Medpoint has experienced consultants ready to help you prepare a plan of action and get back on track as soon as possible.
Whatever your need, Medpoint is ready partner with you to ensure your supplier controls are the best they can be. Contact us today!