The U.S. FDA regulates animal drugs, feed, and veterinary products to ensure the safety, quality, and efficacy of products for animals. Compliance with FDA regulations, including 21 CFR Part 514 and FSMA (Food Safety Modernization Act), is mandatory for manufacturers, distributors, and importers. Proper registration, labeling, and reporting are critical for market access and to avoid enforcement actions.

At XPRO AMERICA, we provide specialized guidance and support for companies producing animal and veterinary products, helping navigate FDA regulatory requirements efficiently.

Key Services:

• Animal Drug Manufacturer Registration (21 CFR Part 514): Domestic and foreign animal drug manufacturers must register their facilities and listed products with the FDA. XPRO AMERICA manages the registration process to ensure timely and accurate submissions.
• Veterinary Feed Directive (VFD) Compliance: VFD drugs require written authorization for use in animal feed. We guide manufacturers and distributors on VFD recordkeeping, labeling, and distribution requirements to comply with FDA regulations.
• Animal Food & Feed Facility Registration (FSMA): Facilities that manufacture, process, pack, or store animal food or feed must register under FSMA. Our team helps ensure proper facility registration, documentation, and compliance with preventive controls.
• Pet Supplement Labeling & Claims Review: Dietary supplements for pets must comply with labeling and ingredient regulations. XPRO AMERICA reviews Supplement Facts Panels, claims, allergens, and warnings to ensure regulatory compliance and avoid misbranding.
• Regulatory Strategy & Ongoing Support: We provide guidance on FDA inspections, post-market compliance, and updates on evolving regulations, ensuring continued market access for animal and veterinary products.

Why Choose XPRO AMERICA?

• Expertise in FDA animal drug and feed regulations.
• Comprehensive support from registration to labeling and VFD compliance.
• Streamlined documentation preparation for FDA submissions.
• Minimizes regulatory risk and ensures safe, compliant products.

Partnering with XPRO AMERICA allows animal drug and feed manufacturers, as well as pet supplement producers, to confidently navigate complex FDA regulations. Our services ensure proper registration, accurate labeling, and adherence to safety and quality standards, protecting both animal health and business interests.

XPRO AMERICA assists animal drug and feed manufacturers with FDA registration, VFD compliance, FSMA facility registration, and pet supplement labeling.