Have you been issued an FDA Form 483 or Warning Letter? We can relate to how stressful and serious this situation is for a company, as our team has been through this process with many people and organizations – including the medical device division of our parent company. We will quickly and deliberately analyze your current situation, try to answer any questions you have, and help you develop and implement a remediation plan that resolves FDA’s concerns and aids in the prevention of future deficiencies.
Our FDA remediation services team, consisting of regulatory, quality system, manufacturing and medical device R&D experts, will help guide you through the 483/Warning Letter resolution process. Our team can help update your product Design History File to meet current standards and comply with quality system requirements. If your Quality System falls short of the current Quality System Regulation (QSR), we can help you bring it into compliance. We have over 30 years of experience interacting with senior-level FDA personnel on legislative, standards, and regulatory questions, including compliance questions, so we can provide help at whatever level is needed. We would welcome the opportunity to put this expertise and experience to work for you to help you resolve the Quality System deficiencies.
Failing to address concerns in an FDA Form 483 or Warning Letter can have implications both financial and reputational. FDA might seize product, stop distribution or require a product recall. We have the resources, experience, and processes to help you resolve the issues.
To resolve your deficiencies efficiently, we carefully take the following steps:
1. Analyze the FDA form 483 or Warning Letter;
2. Interview key members of your team and review supporting documentation
3. Answer any questions you have about your situation;
4. Develop and implement a custom remediation plan, with a timeline that meets expectations, based on your unique situation.
5. Help you manage the remediation plan, adjusting as new information comes to light.