Inspections & Audit Preparation
Expert preparation for FDA inspections, ISO audits, and regulatory reviews to ensure confident compliance.
Facing an upcoming FDA inspection or regulatory audit can be stressful, especially without proper preparation. Our inspection and audit preparation services ensure your team is confident, your documentation is organized, and your facility is ready.
We conduct thorough mock inspections that simulate real regulatory visits, identifying potential findings before inspectors do. Our experienced consultants know what auditors look for because many of us have been on both sides of the table.
Beyond preparation, we help you build sustainable audit readiness into your daily operations so that inspections become routine events rather than crises.
Key Benefits
- Mock inspections that simulate real FDA and ISO audit scenarios
- Documentation review and organization for audit readiness
- Staff training on inspector interactions and best practices
- CAPA system review and remediation support
- Post-audit response assistance and corrective action planning
Frequently Asked Questions
How far in advance should we start audit preparation?
We recommend starting at least 3 to 6 months before a scheduled audit. For unannounced FDA inspections, we help build ongoing audit readiness into your operations so you are always prepared.
What does a mock inspection involve?
A mock inspection follows the same format as a real regulatory inspection. We review documentation, tour your facility, interview staff, and deliver a detailed report of observations — just as an auditor would — giving you time to address any issues.
Can you help with FDA 483 responses?
Yes. We help draft comprehensive and timely responses to FDA 483 observations and warning letters, including corrective action plans that demonstrate your commitment to compliance.