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FDA Food Facility Registration: A Comprehensive Guide for Manufacturers
If your company manufactures, processes, packs, or holds food or dietary supplements for U.S. consumption, you may be required to complete FDA Food Facility Registration (FFR) . This guide explains: Who must register How to obtain a DUNS (UFI) Domestic vs. foreign requirements U.S. Agent requirements Biennial renewal deadlines Common mistakes that cause delays This article applies to food and dietary supplement facilities only . It does not apply to OTC drug registration or
Feb 224 min read
FSVP Compliance in Audits: FSVP and Quality Audits - Why They Matter
Foreign Supplier Verification Program (FSVP) compliance is a critical component for companies involved in the importation of pharmaceutical, nutraceutical, cosmetic, and biotech products into the United States. Understanding the role of FSVP in quality audits is essential for ensuring product safety, regulatory adherence, and market access. In this post, I will explain why FSVP compliance in audits matters, how it impacts your operations, and what practical steps you can take
Feb 164 min read
Understanding MoCRA: Serious Adverse Event Reporting for Cosmetic Companies
Introduction to MoCRA Cosmetic companies marketing products in the United States are now navigating the most significant regulatory reform in decades: the Modernization of Cosmetics Regulation Act (MoCRA) . This law introduces structured serious adverse event (SAE) reporting , documented safety substantiation, facility registration, and enforceable oversight. At the same time, companies marketing in the European Union must comply with EU Regulation (EC) No 1223/2009 . This re
Feb 144 min read
DUNS Registration Insights: DUNS Number and FDA Facility Registration Explained
Navigating the regulatory landscape for pharmaceutical, nutraceutical, cosmetics, and biotech products requires precise compliance steps. One critical element in this process is understanding the role of the DUNS number and facility registration. These identifiers are essential for companies aiming to enter and operate within the US market, especially when dealing with the US Food and Drug Administration (FDA). This post breaks down what these registrations mean, who needs th
Feb 104 min read
Understanding the Role of US FDA Agent
Entering the US market requires strict compliance with the Food and Drug Administration (FDA) regulations. For global pharmaceutical, nutraceutical, cosmetics, and biotech manufacturers, understanding the role of a US FDA agent is essential. This agent acts as a bridge between foreign companies and the FDA, ensuring smooth communication and regulatory adherence. In this post, I will explain the responsibilities of a US FDA agent, the registration process, and how partnering w
Feb 24 min read
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