FDA 483 Remediation Response
Ensure a Smooth Resolution for Non-compliance Challenges
A Form 483 from the FDA can be a stressful and disruptive event, raising concerns about compliance and impacting your business. But it doesn’t have to be a setback. At AlvaMed, we offer comprehensive support to help you navigate the FDA 483 response process effectively and efficiently toward a smooth resolution.
Accurately assess the root cause and potential impact of each observation is crucial for developing an effective response.
Formulate a comprehensive CAPA with clear timelines, responsible parties, and corrective actions for each observation requires expertise in regulatory requirements and quality systems.
We understand the importance of timely response deadlines. We work diligently to meet all FDA timeframes.
We draft clear and concise responses you can provide to the FDA, ensuring all observations are comprehensively addressed.
We offer ongoing support throughout the response process and can answer any questions you may have.
We have a proven track record of helping companies successfully navigate FDA 483 inspection responses.
We were working on a very tight deadline to submit 483 responses to the FDA with extremely limited resources to get the job done. We hired AlvaMed to help us, and they were able to on-board, advise us on strategy, work with our team, and draft responses to our findings in less than 2 weeks. Before bringing the AlvaMed team on, we worried this would not be an achievable task. We were thrilled with the outcomes and our team gained an incredible amount of knowledge in working with AlvaMed’s experts. I would highly recommend AlvaMed to any company requiring QA/RA support.
Directory of Quality
International Med-Tech Company
We were in search of a consulting firm to assist us in tailoring our existing quality management system to meet our specific requirements. That’s when we engaged AlvaMed, and I must say, their performance was truly outstanding.
AlvaMed swiftly grasped the intricacies of our unique needs and hurdles, crafting a bespoke solution that perfectly aligned with our objectives. Their adeptness in implementing the new system, conducting internal audits, and delivering design assurance support was not only impressive but also executed seamlessly, adhering to both our schedule and budget constraints.
I recommend AlvaMed to any medical device company in search of a consulting partner. Their competence and commitment are second to none, and they have undoubtedly been instrumental in our success.
Kelly Ashfield
Materna
AlvaMed’s dedication to quality and compliance is truly commendable. Their prompt and transparent actions in addressing the DHF audit findings showcase their commitment to excellence. What stands out to me is their meticulous gap assessment and proactive approach to risk management, which clearly illustrates their commitment to continuous improvement. I’m confident in their ability to maintain these high standards and look forward to continued collaboration.
Angel Iglesias
Anika
I’d like to take a moment to express my gratitude for AlvaMed’s quick response, experience and professional approach to addressing our efforts to respond to an audit finding. AlvaMed conducted a comprehensive assessment of our product technical documentation, identified gaps related to current standards and regulations, and provided a clear definition of objectives and a plan to address the gaps.
I am thoroughly satisfied with the level of expertise and diligence displayed by AlvaMed throughout this process. Without hesitation, I would highly recommend them to any medical device company seeking a consulting company to address compliance concerns.
Erik Williams
Anika
We are extremely satisfied with the quality support services provided by AlvaMed. Their expertise in the medical device industry, tailored solutions, and transparent communication have been invaluable to our operations at Goddard Technologies, Inc. We highly recommend their services to anyone seeking top-notch quality support.
Charlie
Goddard Technologies, Inc.
We are delighted to express our appreciation for the exceptional quality engineer support provided by AlvaMed. With AlvaMed’s guidance, we’ve not only met regulatory requirements but have also exceeded our own quality benchmarks. AlvaMed has proven to be a valuable partner in our pursuit of excellence, and we highly recommend their services to anyone seeking top-tier quality engineering support.
David Davilla
MMS
FDA 483 Remediation Response FAQ's
What should I do if I receive an FDA Form 483?
- Carefully analyze each observation to understand the concerns raised by the FDA.
- Consider partnering with an experienced regulatory consultant who can help you navigate the response process effectively.
How long do I have to respond to an FDA Form 483?
The FDA typically expects a response to a Form 483 within 15 business days. Meeting this deadline demonstrates your commitment to addressing their concerns.
What happens after I submit my response to the FDA?
Depending on the severity of the observations, the FDA may:
- Close the case: If the response addresses the observations adequately.
- Request additional information: The FDA might require further clarification on specific observations.
- Schedule a follow-up inspection: In some cases, the FDA may conduct a follow-up inspection to verify the implementation of corrective actions.
Brian Ludovico
Director of Quality Affairs
Don’t let an FDA 483 derail your progress. Contact us today to schedule a consultation and discuss how we can help you achieve a successful outcome.
