IA #57-10 - 4/17/98, IMPORT ALERT #57-10, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF HTLV BLOT 2.4 AND HIV-1 BLOT 1.3 FROM
GENELABS DIAGNOSTICS PTE, LTD, SINGAPORE"
TYPE OF ALERT: Detention Without Physical Examination.
(Note: This import alert represents the Agency's current guidance to FDA field personnel
regarding the manufacturer and products at issue. It does not create or confer any rights for or on
any person and does not operate to bind FDA or the public.)
PRODUCTS : HTLV Blot 2.4 and HIV-1 Blot 1.3.
PRODUCT CODE : 57YY99
PROBLEM : No U.S. license, misbranding.
(OASIS Charge Codes = DIRECTIONS & NO LICENSE)
PAC : 42R825
PAF : LBL & REG
COUNTRY : Singapore, (SG), 795
MANUFACTURER/
SHIPPER : Genelabs Diagnostics PTE LTD
85 Science Park Drive, #04-01,
The Cavendish
Singapore Science Park
Singapore
MANUFACTURER/
SHIPPER ID # : FEI #1000436598
IMPORTER'S : N/A
I.D.#
CHARGE : "The article is subject to refusal of admission pursuant to Section 801
(a)(3) in that the article appears to be a biological product manufactured at
an establishment that does not hold an unsuspended and unrevoked license
issued under the Public Health Service Act, section 351, Section 351(a)
[Misbranding, Section 502(f)(1) & PHS Act Section 351(a)]."
"The article is subject to refusal of admission pursuant to Section 801(a)(3)
in that the labeling of the article does not appear to contain adequate
directions for use, and the article does not appear to be exempt from such
requirements [Misbranding, 502(f)(1)]."
and
"The article is subject to refusal of admission pursuant to Section 801(a)(3)
in that the labeling for the article appears to be false or misleading
[Misbranding, Section 502(a)]."
RECOMMENDING
OFFICE : SAN-DO Import Operations Branch, HFR-PA152.
REASON FOR
ALERT : In May of 1996, the Center for Biologics Evaluation and Research (CBER)
responded to a request from Genelabs Diagnostics (Genelabs) for guidance
as to regulatory requirements associated with the sale of an in vitro
diagnostic (IVD) device, HTLV Blot 2.4, for research use. CBER
informed Genelabs that the labeling for the HTLV Blot 2.4 they provided
did not meet the definition of a research use only or investigational use
IVD device, in part because the indicated end users of the device would be
hospitals and blood banks, facilities which do not routinely perform IVD
research. Therefore, the article was not exempt from IVD labeling
requirements under 21 CFR 809.10(c)(2)(i). In addition, CBER advised
the firm that the importation of the IVD device into the U.S. for sale,
barter, or exchange would require that the product be licensed in
accordance with Section 351(a) of the Public Health Service Act. CBER
also advised the firm that, as an alternative, the IVD device could be legally
imported into the U.S. for a clinical investigation if an Investigational New
Drug (IND) application was filed by the sponsor and the filing was
accepted by CBER. Genelabs does not hold an unsuspended and
unrevoked U.S. license for its Singapore establishment or for the IVD
device products and does not have an accepted IND for these products.
In July 1997, HTLV Blot 2.4 and HIV-1 Blot 1.3 IVD devices
manufactured by Genelabs were offered for import and subsequently
refused. The IVD devices were invoiced as being for research use only;
however, the labeling, i.e., container labeling and package inserts, did not
follow the requirements of 21 CFR 809.10(c)(2)(i) regarding the intent of
"research use." Therefore, the IVD devices were not exempt from IVD
labeling requirements of 21 CFR 809.1 making them misbranded under
Section 502(a).
Note also that the IVD devices do not contain adequate directions for use,
causing them to be misbranded under Section 502(f). In addition, the IVD
devices are not exempt from such requirements, because they do not hold
an IND accepted by CBER, and Genelabs does not hold an unsuspended
and
unrevoked U.S. license for its Singapore establishment or for the IVD
devices. In addition, the IVDs are not exempt from complying with the
requirements, because their labeling does not comply with 21 CFR 809.10
(see 21 CFR 801.119).
GUIDANCE : Districts may detain without physical examination HTLV Blot 2.4, and
HIV-1 Blot 1.3 manufactured by Genelabs Diagnostics PTE LTD,
Singapore.
For questions or issues concerning science, science policy, sample
collection, analysis, preparation, or analytical methodology, contact the
Division of Field Science at (301) 443-3320 or 3007.
FOI : No purging required
PREPARED BY : Alwin W. Collins, Operations & Policy SDWG, DIOP, (301) 443-6553
KEYWORDS : HIV-1 Blot 1.3, HTLV Blot 2.4, IVD, IVD device, Genelabs, Singapore.
Date Loaded
into FIARS : April 17, 1998
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