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