From Amazon reinstatements to FDA import alert removals — see how we've helped brands navigate FDA compliance.
Challenge: The client needed urgent MoCRA compliance to avoid shipment holds at US Customs. With 50+ SKUs and no US presence, they were at risk of significant revenue loss during peak season.
Challenge: Top-selling product listing suspended by Amazon due to prohibited FDA disease claims on labels and listing images. Primary revenue stream at risk.
Challenge: Manufacturer wanted to export surgical masks to the US but was confused by FDA's device classification and registration requirements, delaying large B2B orders.
Challenge: Repeated shipment detentions at US border under FDA Import Alert due to misbranding and missing nutritional information. Mounting demurrage fees and lost sales.
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FDA Regulatory Advisor · KECC