Import Alert 57-10
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) 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).
Import Alert # 57-10
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Detention Without Physicla Examination of HTLV Blot 2.4 And HIV 1 Blot 1.3 From Genelabs Diagnostics Pte, Ltd, Singapore"
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).
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, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301 796-5992.
For questions or issues concerning science, science policy, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301 796-5992.
Product Description:
HTLV Blot 2.4 and HIV 1 Blot 1.3 IVD devices
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)]."
OASIS Charge code - NO LICENSE
and
"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)]."
OASIS Charge code - DIRSEXMPT
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)]."
OASIS Charge code - FALSE
OASIS Charge code - NO LICENSE
and
"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)]."
OASIS Charge code - DIRSEXMPT
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)]."
OASIS Charge code - FALSE
SINGAPORE
Genelabs Diagnostics Pte Ltd.
Date Published : 09/10/2009
85 Science Park Drive ,#04-01 the Cavend , Singapore Science Park , Singapore, SINGAPORE
57 Y Y - 99 Biologics and Licensed In-Vivo and In-Vitro Diagnostics, N.E.C.
Date Published: 09/10/2009
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