Cosmetic manufacturers, packers, and distributors selling products in the United States must be prepared for FDA inspections and audits. With the implementation of the Modernization of Cosmetics Regulation Act (MoCRA), FDA inspections of cosmetic facilities are expected to increase, making compliance readiness more critical than ever. Companies that are unprepared may face inspectional observations, warning letters, import alerts, or even product recalls.

Preparing for an FDA inspection requires more than just compliant product labeling it involves a comprehensive compliance management system that includes robust documentation, facility hygiene, production controls, and adverse event reporting. Being inspection-ready ensures smoother FDA interactions and protects both brand reputation and consumer trust.

At XPRO America, we specialize in guiding cosmetic companies through mock audits, documentation reviews, and corrective action planning to achieve full inspection readiness. Our services include:

• Mock FDA Audits – Simulating real FDA inspections to identify compliance gaps.
• Documentation Preparation – Ensuring facility records, SOPs, ingredient safety assessments, and labeling documents are audit-ready.
• Corrective Action Support – Guiding companies in resolving deficiencies identified during internal audits or FDA inspections.
• Regulatory Training – Preparing staff to confidently manage FDA inspector interactions.
• Ongoing Compliance Monitoring – Keeping facilities updated with the latest MoCRA and FDA regulations.

FDA inspections typically evaluate:

• Facility cleanliness and hygiene practices.
• Recordkeeping for ingredient compliance and safety substantiation.
• Proper labeling and claims management.
• Complaint handling and adverse event reporting systems.

By partnering with XPRO America, cosmetic companies can proactively reduce compliance risks, avoid costly enforcement actions, and maintain uninterrupted access to the U.S. market. With regulatory standards becoming stricter under MoCRA, inspection and audit readiness is no longer optional it is a business necessity.

XPRO America helps cosmetic companies prepare for FDA inspections with mock audits, documentation support, and corrective action planning for full compliance readiness.