Different forms of heparin and heparin-related products

Why FDA issued it

Note: The revision of this Import Alert (IA) dated 08/2/2024 updates the reason for alert, guidance, agency contacts, product description section, charge code section, PAF, PAC. Changes to the import alert are bracketed by asterisks (***). ***On July 21, 2014 the charge code was revised within the Alert to include authority set forth in section 501(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) making a drug adulterated if it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection. Articles of drug falling within this new section are subject to refusal under 801(a)(3) of the FD&C Act. To date firms in violation of 501(j) are now placed on Import Alert 66-79,"Detention Without Physi

Quoted from the “Reason for Alert” section of the FDA page for 55-03, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.