Import Alert 57-11

Import Alert # 57-11

Published Date: 04/18/2023

Type: DWPE

"DETENTION WITHOUT PHYSICAL EXAMINATION OF UNLICENSED IMMUNE GLOBULIN INTRAVENOUS (HUMAN)"

Note: The revision of this Import Alert (IA) dated 04/18/2023 updates the IA name, guidance section including agency contacts, charge code language, product description section, and PAC. Changes to the import alert are bracketed by asterisks (***).

Foreign establishments having a U.S. license for the manufacture of IGIV also manufacture unlicensed versions of IGIV for other countries. Only IGIV manufactured under the U.S. license and bearing the U.S. license number on its labeling may be imported into the United States unless the unlicensed version of IGIV has an Investigational New Drug (IND) application accepted by the Center for Biologics Evaluation and Research.

Divisions may detain without physical examination foreign manufactured and unlicensed versions of Immune Globulin Intravenous (Human) IGIV identified on the Red List of this import alert.

Divisions encountering a shipment of foreign manufactured IGIV should determine whether the IGIV is covered by an unrevoked and unsuspended U.S. license or an accepted Investigational New Drug (IND) application. This can be done by checking the CBER website: *** https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/immune-globulins. *** This website lists all currently approved IGIV products, manufacturers, and indications for use. To verify if an IND is in effect for the IGIV product check the CBER tab of Center Views located in ORA applications.

Divisions should submit a recommendation for addition to the Red List when detained products appear to meet the criteria in this alert and are not listed on the Red list of this import alert. DIO and FDA's Center for Biological Evaluation and Research will evaluate regulatory recommendations on a case-by-case basis.

***Removal from Detention Without Physical Examination (REMOVE FROM RED LIST):

In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of a violation. The purpose of this is so the agency will have confidence that future entries will be in compliance with the FD&C Act. For guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention Without Physical Examination (DWPE)"

If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:

Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or, be sent via email to: Importalerts2@fda.hhs.gov

Requests for removal from DWPE will be reviewed by DIO and referred to CBER for additional evaluation.

Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov

Questions related to criteria and/or products covered may be directed to the CBER's Office of Compliance and Biologics Quality, Division of Case Management at CBERImportInquiry@fda.hhs.gov.

                                                                                                                                                                ***

***Immune Globulin Intravenous (Human)***

"The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1) of the FD&C Act because it fails to bear adequate directions for use. [Section 801(a)(3), 505, 502(f)(1); UNAPPROVED, MISBRANDED & PHS ACT]

OASIS Charge Code: NO LICENSE

And/or

***" The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use." [Section 502(f)(1), 801(a)(3); MISBRANDING]***

OASIS charge code: DIRSEXMPT

Desc: Immune Globulin Intravenous

Notes: 09/10/2009

Desc: Immune Globulin Intravenous

Notes: 09/10/2009