In the highly regulated pharmaceutical and healthcare industry, compliance with the U.S. Food and Drug Administration (FDA) is not optional it is a business necessity. When drug products are found to be misbranded, adulterated, or unsafe, the FDA may require a recall or initiate enforcement actions. Mishandling a recall can lead to severe financial losses, legal consequences, and reputational damage.

XPRO America provides expert Product Recall & Enforcement Guidance services to help companies navigate FDA’s regulatory framework with confidence. Our team specializes in developing recall strategies, managing communication with the FDA, and supporting companies through every step of the enforcement process.

A recall is more than just removing products from the market it is about demonstrating to the FDA that your company can act responsibly, protect public health, and maintain compliance. At XPRO America, we support clients in:

• Recall Strategy Development: Designing customized recall plans that align with FDA requirements while minimizing disruption to your business operations.
• Risk Assessment & Classification: Assisting in determining whether the recall falls under Class I, II, or III, and managing appropriate response actions.
• FDA Liaison & Communication: Acting as your point of contact with the FDA during recall investigations, enforcement actions, or follow-up inspections.
• Documentation & Reporting: Preparing accurate recall notifications, progress reports, and closure requests in compliance with FDA expectations.
• Corrective Action Support: Developing long-term compliance strategies to prevent recurrence of misbranding, adulteration, or safety violations.

By working with XPRO America, companies gain access to regulatory expertise that ensures recalls are handled efficiently and with full FDA cooperation. We help mitigate business risks, protect consumer trust, and maintain regulatory compliance even during challenging enforcement scenarios.

Whether you are managing a voluntary recall or facing an FDA-initiated enforcement action, our team ensures your business responds with speed, accuracy, and credibility.

XPRO America helps pharma companies with FDA product recall guidance, enforcement support, FDA liaison, documentation, and corrective action planning