Overview
FDA inspections of foreign establishments are a critical event that requires careful preparation and coordination. As your US Agent, we serve as the initial point of contact when FDA announces an inspection of your facility. We help coordinate scheduling, ensure you have adequate time to prepare, and can provide pre-inspection readiness support to help you put your best foot forward. Our goal is to help you demonstrate compliance and address any FDA concerns professionally.
Key Features
Our Process
Notification Receipt
When FDA announces an inspection, we immediately notify you and begin coordination.
Scheduling Coordination
We work with FDA to confirm inspection dates and provide them your facility contacts.
Preparation Support
We offer pre-inspection readiness reviews and mock inspections to identify potential issues.
Post-Inspection Follow-up
If FDA issues observations (483s), we help you prepare thorough, compliant responses.
Frequently Asked Questions
Relevant Regulatory Guidance
Why Choose Us
- Maximum preparation time when FDA announces an inspection
- Professional coordination with FDA investigators
- Identified and addressed gaps before FDA arrives
- Reduced anxiety with clear inspection protocols
- Expert support for 483 responses if needed
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Contact our team to discuss your specific needs for Inspection Support.
Schedule ConsultationWhat Our Clients Say
"Adelphi's pre-inspection mock audit identified three significant issues we hadn't recognized. We fixed them before FDA arrived, and the actual inspection resulted in only minor observations. Their inspection preparation was worth every penny."
Paolo Rossi
QA Director
Italian Drug Manufacturer
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