FDA Remediation Services
FDA Inspection? 483 or Major Observation? Warning Letter? Product Recall? Reportable Event?Keep calm, assistance is en route!
In the realm of manufacturing medical or in vitro diagnostic devices, emergencies are inevitable. The FDA retains the authority to conduct inspections at any given moment, often with minimal notice. MEDIcept has years of experience with FDA 483 response consulting and remediation services to ensure that you have a swift, cost-efficient resolution. Facing regulatory challenges can be an exhausting and financially draining ordeal if you don’t know how to respond with care and consideration. We’re here to support you every step of the way.
Services provided:
- FDA inspection front room and back room assistance
- Corrections and removals strategy and management
- Vigilance and MDR reporting strategy
- FDA 483 or Warning Letter response
- Major ISO or CE Mark Observation
- US Customs detention
- BIMO audit support
FDA Inspections
FDA inspections may occur with brief advance notice or without any warning at all. On the international stage, inspections can be announced with as little as a six month notice. Feeling stressed? Our seasoned team understands your position intimately; we've faced FDA Investigators and ISO Auditors head-on, defending Quality Management Systems. We're subject matter experts that coach our clients before FDA inspectors arrive and offer guidance to ensure your compliance remains steadfast.
Corrections and Removals
Navigating a potential domestic or international product recall demands a clear starting point and precise timing for notifying the relevant authorities. Each decision hinges on a meticulous risk/benefit assessment while demanding careful handling to safeguard patient well-being and reduce potential harm to your company's reputation and financial standing. Without adequate experience, the journey can quickly spiral into a complex and costly endeavor. Our team can streamline this process, ensuring you navigate the recall with confidence and efficiency.
Inspection or Audit Observation Response
Have you just undergone an FDA inspection or an ISO/CE Mark audit, finding yourself with a 483 or a Major Observation? What you need now is a seasoned team of consultants to provide expert advice, identify root causes, craft a comprehensive response, and strategize for effective remediation, ensuring your company progresses smoothly while keeping regulatory authorities satisfied. Even if you've already submitted a response that hasn't been accepted, it's not too late to get in touch with our expert team! Let us be your trusted partner that does the hard work in navigating these challenges.
I need help NOW!
Did you just receive a 483 notice or an FDA warning letter? Relax. We can help. Let our regulatory emergency response team show you how.
Need FDA or EU MDR/IVDR audit assistance?
Don’t do it alone. Our deep, firsthand experience with FDA and EU MDR/IVDR audits can help you protect your business by minimizing risk and disruption.
Are you a start-up?
We’ve helped a wide range of start-ups develop effective regulatory strategies to obtain FDA and EU MDR clearances. We’ll work with you to develop an appropriate domestic or global regulatory strategy to help ensure compliance and product approvals.