For FDA-regulated industries such as food, cosmetics, dietary supplements, and pharmaceuticals, preparing for an FDA inspection is essential to ensure uninterrupted market access. Inspections are designed to verify compliance with U.S. Food and Drug Administration (FDA) regulations, including cGMP (Current Good Manufacturing Practice), labeling requirements, and safety standards. Companies that fail to demonstrate compliance may face warning letters, product recalls, import detentions, or even facility shutdowns.

XPRO America specializes in FDA inspection and audit readiness services, helping both domestic and foreign companies prepare effectively. We understand that FDA audits can be stressful, but with the right preparation, organizations can confidently demonstrate compliance and reduce regulatory risks.

Our inspection readiness support includes:

• Mock FDA Audits: Simulated inspections that follow FDA’s inspection protocol to identify gaps in compliance before the real inspection occurs.
• CAPA (Corrective and Preventive Action) Planning: Development of structured CAPA programs to address compliance gaps and prevent recurrence.
• Documentation Review: Ensuring that SOPs, batch records, labeling files, and quality management documentation are complete, accurate, and inspection-ready.
• Employee Training: Preparing staff for FDA interviews and guiding them on how to respond to inspection questions with clarity and accuracy.
• Post-Inspection Support: Assistance in responding to FDA Form 483 observations or warning letters with well-documented corrective actions.

Proactive inspection readiness ensures that your business avoids costly enforcement actions and maintains FDA’s confidence in your operations. Whether you are undergoing your first FDA inspection or preparing for a re-inspection, XPRO America provides tailored solutions to keep you compliant and prepared at all times.

With our end-to-end FDA compliance expertise, we help companies strengthen internal controls, improve quality management systems, and align operations with U.S. regulatory standards.

XPRO America offers FDA inspection & audit readiness services with mock audits, CAPA planning, and compliance documentation support for regulated industries.