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News / Insights
News & Blog
Regulatory updates. Practical perspectives.
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Blog: Blog2
FDA Warning Letter to Zhejiang Gaorong Cosmetic: Why Quality Control Matters for Cosmetic and OTC Manufacturers
A recent FDA Warning Letter highlights the importance of raw material verification, supplier qualification, and independent quality oversight. For companies manufacturing cosmetics and OTC products for the U.S. market, the case offers an important lesson: product quality must be supported by a reliable and documented quality management system. 1. A Recent FDA Warning Letter: What Happened? On October 1, 2026, the U.S. Food and Drug Administration (FDA) issued a Warning Letter
Provision Consulting Group
6 hours ago6 min read
Your Device Is FDA-Cleared. Who Is Your U.S. Initial Importer?
A 510(k) clearance or a registered listing proves your device may be marketed in the United States. It does not answer a different question that comes up the moment your first shipment arrives: who in the U.S. is accountable for that device, and what happens if something goes wrong? That accountability sits with the FDA Initial Importer. Many foreign manufacturers treat it as a registration formality. It is closer to a standing commitment. Consider a case described in an Octo
Provision Consulting Group
Nov 64 min read
FDA Finalizes Mandatory Cosmetics Recall Guidance: What K-Beauty Brands Entering the U.S. Should Know
The U.S. Food and Drug Administration (FDA) has finalized its guidance on Mandatory Cosmetics Recalls, providing more clarity on how the agency may exercise its recall authority under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The final guidance, issued in October 2026, addresses common questions about the criteria, process, and expectations surrounding mandatory recalls of cosmetic products. For Korean beauty brands planning to enter the U.S. market, the
Provision Consulting Group
Oct 304 min read
Renew Your FDA Initial Importer Designation with Provision
The FDA renewal period for medical device establishments runs October 1 – December 31, 2026. This includes your U.S. Initial Importer. FDA fee for FY2027: $13,785 per establishment Initial importers must register and pay FDA’s annual establishment registration fee, just like manufacturers. By designating Provision as your Initial Importer, you avoid setting up and paying for your own initial importer registration. Why does this matter? Every foreign-made medical device sold i
Provision Consulting Group
Oct 161 min read
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