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 - 9/18/08
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 9/18/08
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 B (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
Sohnen de Mexico, S De C.V. Microwave Ovens - All
No 14603 Calle Mazatlan Makes and Models, 96R[][]CR
Tijuana, Mexico 96R[][]CS
FEI# 1000257004 96M[][]01
3001600177 9/18/08
TCL Holdings Co., Ltd. TV receivers/computer monitors/
No. 6 Eling South Road 94V[][]07
Huizhou City, China 6/1/01
FEI# 3003330199
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