Our Approach
Services
Audit Recovery & Issue Resolution
Support when FDA requests records, issues observations, or identifies gaps
If you receive an FDA FSVP record request, Form 483 observation, or notice of non-compliance, we help you respond in a clear, structured, and timely manner. Our team reviews the findings, identifies what documentation is needed, and prepares responses that align with FSVP requirements.
What’s included
- Review of FDA letters, record request letters, Import Alert 99-41 issues, or Form 483 observations
- Analysis of existing documentation and identification of missing records
- Corrective-action guidance based on the specific findings
- Preparation of FSVP records for submission
- Coordination to collect the required documents
- Drafting structured, professional responses to FDA questions
- Support with follow-up requests until the issue is resolved
Deliverables You Receive
- A clear plan to address FDA’s findings
- Prepared documentation aligned with FSVP requirements
- Corrective-action recommendations and tracking support
- Written responses to submit to FDA
- Guidance throughout the resolution process
- Prioritized handling for time-sensitive situations
How This Supports Compliance
Timely and organized responses help prevent escalation, shipment delays, and additional observations. Structured corrective actions demonstrate that the importer understands the requirements and is taking appropriate steps to meet them, which supports smoother resolution with FDA.
Request a Quote
We can help assess the situation and outline next steps based on the notice or findings you received.