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FDA Inspection & Audit Readiness Services for Compliance – XPRO AMERICA

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 [...]

Medical Device Registration & Listing Compliance – XPRO AMERICA

All medical device manufacturers, repackers, relabelers, specification developers, and initial importers must comply with FDA regulations for establishment registration and device listing under 21 CFR Part 807. Annual registration ensures FDA oversight of facilities marketing devices in the United States, while device listing identifies each medical device available in the [...]

Device Classification & Regulatory Pathway – XPRO AMERICA

Proper device classification and regulatory pathway determination are essential first steps for marketing medical devices in the United States. The FDA classifies devices as Class I, II, or III, based on risk level, intended use, and regulatory controls. Choosing the correct submission route 510(k), De Novo, or PMA (Premarket Approval)—is [...]

De Novo Device Classification & FDA Support – XPRO AMERICA

The De Novo classification pathway is designed for novel, low- to moderate-risk medical devices that do not have a predicate device for 510(k) submission. This pathway allows manufacturers to obtain FDA marketing authorization by demonstrating safety and effectiveness while establishing a new device classification. At XPRO AMERICA, we provide expert [...]

Annual & Ongoing FDA Compliance Services – XPRO AMERICA

For companies regulated by the U.S. Food and Drug Administration (FDA), compliance is not a one-time process but an ongoing responsibility. Each year, manufacturers, distributors, importers, and other regulated entities must renew their establishment registration and update product listings to remain in good standing with the FDA. In addition, regulatory [...]

510(k) Premarket Notification & Clearance Support – XPRO AMERICA

The 510(k) Premarket Notification is the primary FDA submission pathway for most Class II medical devices. It demonstrates that a new device is substantially equivalent to a legally marketed predicate device. Proper preparation, documentation, and FDA interaction are critical for timely clearance and market access in the United States. At [...]

XPRO America – US FDA Drug Establishment Registration (21 CFR Part 207)

The US FDA Drug Establishment Registration is a mandatory requirement under 21 CFR Part 207 for all facilities engaged in the manufacturing, repacking, relabeling, or distribution of human and veterinary drugs intended for the U.S. market. This regulation applies to both domestic and foreign facilities, ensuring that all establishments involved [...]

XPRO America – FDA Product Recall & Enforcement Guidance Services

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 [...]

XPRO America – FDA Post-Market Reporting & Pharmacovigilance Support

Pharmaceutical companies must ensure the safety and effectiveness of their products even after FDA approval and U.S. market entry. This ongoing responsibility is managed through post-market reporting and pharmacovigilance programs, which play a critical role in identifying, assessing, and mitigating potential risks associated with human and veterinary drugs. The U.S. [...]