FDA Import Alert 95-05

Why FDA issued it

Note: The revision of this Import Alert (IA) dated 12/29/2022 updates the guidance section including the agency contacts, and charge section. Changes to the import alert are bracketed by asterisks (***). Reason for Alert: The firms listed on the Red List for this alert, have been found to have one or more of the following objectionable conditions: 1) are subject to a CDRH Quality Control and Testing Program disapproval in accordance with section 534(h) of the FD&C Act, or; 2) do not appear to comply with the applicable performance standards prescribed pursuant to section 534 of the FD&C Act, or; 3) do not have the certification required by section 534(h) of the FD&C Act and as specified in 21 CFR 1010.2. These conditions may include products without a permanently affixed label or tag, products for which evidence of a valid test and quality control program is lacking, or products for whic

Quoted from the “Reason for Alert” section of the FDA page for 95-05, mirrored 18 October 2026. The quotation is truncated at the length this copy carries.