Import Alert 95-05
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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 # 95-05
Published Date: 02/14/2013
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Electronic Products That Fail to Comply with Performance Standards or No Certification"
Reason for Alert:
The manufacturers listed in the attachment is under a CDRH Quality Control and Testing Program disapproval in accordance with section 534(h) for the product listed in the attachment.
Guidance:
Districts may detain without physical examination (DWPE) shipments of identified electronic products from the manufacturers/shippers identified in the attachmnet to this alert. The firms listed in the attachment have failed to provide a valid test and quality control program, thus invalidating the certification label.
Products that are detained may subsequently be refused admission unless the importer is able to show that the products meet all applicable performance standards. It may be necessary to audit some products to ensure the importer has made the appropriate corrections.
CDRH should be contacted for additional guidance and for information regarding submission of required reports (Henry Knox or Thomas M. Jakub, (301) 594-4591, for diagnostic imaging products or Debbie Clingan, (301) 594-4654, for all other electronic products.)
Products that are detained may subsequently be refused admission unless the importer is able to show that the products meet all applicable performance standards. It may be necessary to audit some products to ensure the importer has made the appropriate corrections.
CDRH should be contacted for additional guidance and for information regarding submission of required reports (Henry Knox or Thomas M. Jakub, (301) 594-4591, for diagnostic imaging products or Debbie Clingan, (301) 594-4654, for all other electronic products.)
Product Description:
Electronic products subject to the Federal Food, Drug, and Cosmetic Act that fail to comply with applicable performance standards.
Charge:
For products that fail to meet performance standards:
"The article is subject to refusal of admission pursuant to section 536(a) in that the article appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed under subchapter C of the Federal Food, Drug, and Cosmetic Act (FFDCA) [NON STANDARD, Section 536(a)]."
OASIS charge code - NON STD
For lack of or false or misleading certification:
"The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product to which is not affixed a certification in the form of a label or tag in conformity with section 534(h)."
OASIS charge code - NO TAG
"The article is subject to refusal of admission pursuant to section 536(a) in that the article appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed under subchapter C of the Federal Food, Drug, and Cosmetic Act (FFDCA) [NON STANDARD, Section 536(a)]."
OASIS charge code - NON STD
For lack of or false or misleading certification:
"The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product to which is not affixed a certification in the form of a label or tag in conformity with section 534(h)."
OASIS charge code - NO TAG
CHINA
Beijing Laserworld Int'l Import & Export, Co., Ltd
Date Published : 10/04/2012
#6-102 Yafangyuan, Shangdi Infor. Ind. B , Haidian, , Changp¿ngqu, Beijingsh¿ CHINA
95 R - - FE Laser Cutter, Material Processing Laser Products
Date Published: 10/04/2012
Desc:Laser Engravers & Cutters (YH-GXXXX series)
95 R - - HK Laser marker or engraver
Date Published: 10/04/2012
Desc:Laser Engravers & Cutters (YH-GXXXX series)
Beijing Shizhengfang Science and Technology Dev. Co., LTD.
Date Published : 02/14/2013
Room 311, Three Gorges Merchant Bldg. , No. 11 Jiuxian Bridge Road Jia , Beijing 100016, Chaoyang District CHINA
90 I - - YL Collimator, Dermatological, Therapeutic X-Ray
Date Published: 02/14/2013
Desc:F7 C02 Fractional Laser
95 R - - DW General Purpose Laser Products, Non-Medical
Date Published: 02/14/2013
Desc:F7 C02 Fractional Laser
95 R - - HL Laser therapy product
Date Published: 02/14/2013
Desc:F7 C02 Fractional Laser
Guangzhou Yue Xiu Enterprises Holdings Corp
Date Published : 09/16/2009
11/F Guangzhou International Trade Bldg. , Guangzhou Dadao Zhong,Guangzhou, China, CHINA
96 M - - 01 Microwave Oven for Food Preparation
Date Published: 09/16/2009
Notes:11/26/2001
Lanxi Yibu Lighting Co.,LTD
Date Published : 10/25/2012
No. 9 Sanziqiao Road , Economic Development Zone , Lanxi, Zhejiang CHINA
95 R - - DX Mercury Vapor Lamp
Date Published: 10/25/2012
Desc:Mercury Vapor Lamp
TCL Holdings Co., Ltd.
Date Published : 09/16/2009
No. 6 Eling South Road , Huizhou, Guangdong CHINA
94 V - - 07 TV Receiver or Product Cont. TV Receiver, Television, Computer Monitor
Date Published: 09/16/2009
Notes:TV Receivers/Computer 6/1/2001
FRANCE
Apelem
Date Published : 09/16/2009
175, Allee Von Neumann , Parc G. Besse , Nimes, Gard, FRANCE
90 J - - AA System, X-Ray, Fluoroscopic, Image-Intensified
Date Published: 09/16/2009
Desc:X Ray System Fluroscopic
Notes:5/30/2003
Notes:5/30/2003
90 J - - AA System, X-Ray, Fluoroscopic, Image-Intensified
Date Published: 09/16/2009
Notes:X-Ray system Fluoroscopic
ITALY
Biorem S.R.L.
Date Published : 09/16/2009
Via F. Angrisani 18A , Agropoli, SA ITALY
79 G - - EX Laser Instrument, Surgical, Powered
Date Published: 09/16/2009
Notes:SkiMaster Micro-dermabrasion products 1/2/2002
79 G - - FD Dermatome
Date Published: 09/16/2009
Notes:SkiMaster Micro-dermabrasion products 1/2/2002
Formenti Seleco S.P.A.
Date Published : 09/16/2009
V. Dante Alighieri, 43 , Lissone, MI ITALY
94 V - - 05 Cathode Ray Tube
Date Published: 09/16/2009
Notes:Television Receivers/Computer Monitors 4/17/2003
94 V - - 07 TV Receiver or Product Cont. TV Receiver, Television, Computer Monitor
Date Published: 09/16/2009
Notes:Television Receivers/Computer Monitors 4/17/2003
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