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.

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We look forward to discussing AlvaMed’s services with you.

Our clients are happy to be references – we are happy to share their contact information when you meet with us.

FDA 483 Remediation Response FAQ's

  • 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.

The FDA typically expects a response to a Form 483 within 15 business days. Meeting this deadline demonstrates your commitment to addressing their concerns.

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.