IA #95-05, 3/23/00 - IMPORT ALERT# 95-05, "DETENTION WITHOUT EXAMINATION OF ELECTRONIC PRODUCTS THAT FAIL TO COMPLY WITH PERFORMANCE STANDARDS OR TO WHICH IS NOT AFFIXED A CERTIFICATION IN THE FORM OF A LABEL OR TAG IN CONFORMITY WITH SECTION 534(h)," Attachment - 8/19/03 TYPE OF ALERT: Detention Without Physical Examination (Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and or product(s) at issue. It does not create or confer any rights for, or on any person, and does not operate to bind the FDA or the public.) PRODUCTS: Electronic products subject to the Federal Food, Drug, and Cosmetic Act that fail to comply with applicable performance standards. PROBLEM: Fails to Meet Performance Standards or fails to meet certification as required by section 534(h) PAF: PER PAC: 86007 COUNTRY: See Attachment Manufacturer/ Shipper: See Attachment 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: 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: NO TAG) RECOMMENDING OFFICE: CDRH/Division of Enforcement I REASON FOR ALERT: The manufacturer 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 listed on the attachment to this alert. The firms listed on 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.) FOI: No purging required. KEYWORDS: Electronic, Performance Standard PREPARED BY: Fredda Shere-Valenti, DIOP, HFC-170 (301) 443-6553 DATE LOADED INTO FIARS: March 23, 2000 Attachment to Import Alert# 95-05 8/19/03 Firms/products that are recommended for DWPE Manufacturer Product/Product Code Apelem X-Ray System Fluoroscopic 175 Allee Von Neumann 90JAA Parc G. Besse 5/30/03 Nimes, Gard France FEI #3000255482 Biorem s.r.l. SkinMaster Micro- Via Angrisani 18/A dermabrasion products 84043 Agropoli (SA) 79--GFD/79--GEX Italy 1/2/02 FEI# 3003494110 Formenti Seleco S.P.A. Television Receivers V. Dante Alighieri, 43 Computer Monitors 20035 Lissone (MI) Italy 94V07 / 94V05 FEI # 3003992769 04/17 /03 Guangzhou Yue Xiu Enterprise Microwave Ovens/96M-01 Holdings Corp. 11/26/01 11/F Guangzhou International Trade Bldg. No. 628 Guangzhou FEI #3002541742 Keitsen Technology (Shenzhen) Co., Ltd. Ultrex (Innova) Brand Microwave Oven Qiaotou Industrial Estate Model 14075 Fuyony Town, Baoan District 96M- - 01 Shenzhen City, China 518103 8/19/03 FEI #3002720095 TCL Holdings Co., Ltd. TV receivers/computer monitors/ No. 6 Eling South Road 94V[][]07 Huizhou City, China 6/1/01 FEI# 3003330199 Sedecal, S.A. (Sociedad Espanola de Electromedicina X-Ray Systems (ALL)/90IZF, y Calidad, S.A.) 90IZG, 90IZH, 90IZI, 90IZJ, Pelaya 9, Poligono Industrial Rio de 90IZL, 90JAA, 90JAB, 90JAC, Janeiro, Madrid E-28110 90KPQ, 90KPR Spain 7/25/01 FEI #3002495042 (Removed X-Ray Generator) 5/14/02