Import Alert 89-04

"Detention Without Physical Examination Of Devices From Firms That Have Not Met Device GMP's"

The revision of this Import Alert, dated 02/25/13 adds information indicating that inspections conducted by foreign or other government inspecting authorities can be a basis for DWPE and guidance on how to remove a firm and product from this alert, and modifies the charge to more closely track the statutory language. Changes are bracketed with asterisks (***).

*** Foreign inspections of device manufacturers are being performed. Detention without physical examination may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP's). ***

*** Detention without physical examination may also be appropriate when FDA receives information concerning inspections conducted by foreign or other government authorities under a Memorandum of Understanding or other agreement that FDA concludes reveal conditions or practices warranting detention of either particular products or all products manufactured by a firm. ***

*** DWPE of such firms remains in effect until such time as FDA is satisfied that the appearance of a violation has been removed, either by reinspection or submission of appropriate documentation to the FDA. ***

*** Districts may detain, without physical sampling and analysis, the indicated device products from the foreign manufacturers noted in the Red List of this import alert.

Foreign manufacturers listed on the Red List of this import alert who would like to request removal from that list should provide information to FDA to adequately demonstrate that the manufacturer has resolved the conditions and/or practices that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance. This may include a letter detailing its corrective actions, accompanied by documentation.

For guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual, Chapter 9, "Detention Without Physical Examination (DWPE)."

If a firm, shipper or importer wishes to request removal from detention without physical examination, they should forward information supporting their request to the Division of Import Operations and to the CDRH Import/Export group.

For questions or issues involving import operations, contact the Division of Import Operations at (301) 796-0356 or CDRH Import/Export group at (301) 796-5500 or cdrhocimport@fda.hhs.gov. ***

All medical devices (*** See Red List ***)

PROBLEM: Failure to Meet Device Good Manufacturing Practices (GMP's)

*** "The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act [Adulteration, Section 501(h) of the FD&C Act]."
OASIS Charge Code: DEVICE GMPS ***