FDA Regulatory Insights & Compliance Guides

FDA Food Facility Registration Renewal 2026: Deadline, Rules and Requirements

FDA food facility registration must be renewed between October 1 and December 31, 2026. Here are the exact dates, the DUNS/UFI and U.S. Agent requirements, what happens if you miss the window, and a six-step renewal checklist.

Feb 224 min read

FSVP Compliance in Audits: FSVP and Quality Audits - Why They Matter

The Foreign Supplier Verification Program (FSVP) is one of the most significant food safety requirements introduced by FSMA. It shifts responsibility for verifying foreign food supplier compliance from the FDA to US importers — creating a direct commercial imperative for foreign food manufacturers to demonstrate compliance with US food safety standards. This guide covers FSVP requirements and their implications for foreign food manufacturers in 2026. What Is FSVP? FSVP requir

Feb 162 min read

Understanding MoCRA: Serious Adverse Event Reporting for Cosmetic Companies

MoCRA introduced mandatory serious adverse event reporting for cosmetic products sold in the United States. For cosmetic brands, importers, and manufacturers, this requirement is a fundamental shift in how consumer complaints and health incidents must be handled. A system that previously involved voluntary reporting now carries legal obligations with specific timeframes, documentation requirements, and FDA oversight. What Is a Serious Adverse Event Under MoCRA? MoCRA defines

Feb 143 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

U.S. AGENT & FDA REGISTRATION

Feb 104 min read

The 5-Step FDA Registration Roadmap for International Manufacturers

Entering the US market is a massive opportunity for pharmaceutical, nutraceutical, and biotech manufacturers. However, the path to market access is guarded by one of the world's most stringent regulators: The FDA. For foreign manufacturers, compliance isn't just about filling out a form—it’s about survival. A single error in your establishment registration or a missed communication from your US Agent can lead to Import Alerts , detained shipments, and costly delays. This guid