FDA Import Alerts

FDA Import Alert: GLP-1 Receptor Agonist Bulk Drug Substances

The FDA has issued Import Alert #66-80, placing Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist Bulk Drug Substances on Detention Without Physical Examination. This action is due to concerns that these substances, used in compounding, may be adulterated and not meet current good manufacturing practice (CGMP) requirements.

FDA Import Alert 16-120: Detention of Non-Compliant Fish Products

The FDA has updated Import Alert 16-120, revising guidance for field personnel regarding the detention without physical examination (DWPE) of fish and fishery products from foreign processors not in compliance with the Seafood HACCP regulation. The update includes changes to the title, reason for alert, and guidance sections, incorporating foreign remote regulatory assessments as a compliance verification method.

FDA Import Alert 98-06: New Tobacco Products Detained Without Authorization

The FDA has updated Import Alert 98-06, which detains new tobacco products lacking required marketing authorization. This revision clarifies guidance and agency contacts, noting that ENDS products are now covered under a separate alert (98-07). Manufacturers and importers must ensure proper authorization to avoid detention.