For companies that manufacture, package, or distribute FDA-regulated products, inspection and audit readiness is critical to maintaining compliance and avoiding enforcement actions. The FDA routinely conducts inspections, including at foreign facilities exporting to the U.S., to ensure adherence to regulatory standards. Lack of preparedness can result in Warning Letters, Import Alerts, product seizures, or even facility shutdowns.

At XPRO AMERICA, we provide complete FDA inspection readiness and audit preparation services designed to help organizations identify compliance gaps, strengthen documentation, and build robust quality systems that withstand FDA scrutiny.

Key Services:

• Mock Audits: We conduct FDA-style mock inspections to simulate real regulatory audits, identifying deficiencies and providing corrective guidance.
• Compliance Documentation Review: Our experts audit Standard Operating Procedures (SOPs), batch records, CAPA files, and training logs to ensure documentation aligns with FDA expectations.
• Foreign Facility Preparation: For non-U.S. manufacturers, we provide specialized guidance on U.S. FDA inspection protocols, ensuring that facilities exporting to the U.S. are fully prepared.
• CAPA (Corrective and Preventive Action) Planning: We help organizations develop and implement CAPA systems to address nonconformities and prevent recurrence.
• Regulatory Training: Our team conducts training sessions for staff to handle FDA inspector interactions, ensuring confidence and professionalism during audits.
• Post-Inspection Support: If issues arise during an FDA inspection, we assist in preparing effective responses and remediation plans to avoid escalation.

Why Choose XPRO AMERICA?

• Experienced team with deep knowledge of FDA inspection protocols.
• Tailored audit readiness programs for pharmaceuticals, medical devices, supplements, and cosmetics.
• Proactive compliance approach to minimize regulatory risks.
• End-to-end support from mock audits to post-inspection corrective actions.

With XPRO AMERICA’s FDA inspection readiness services, your company can approach FDA audits with confidence, knowing that your documentation, systems, and staff are fully aligned with U.S. regulatory requirements. Our proactive strategies not only minimize risks but also strengthen long-term compliance culture.

XPRO AMERICA prepares companies for FDA inspections with mock audits, CAPA planning, and compliance documentation for smooth regulatory readiness.