IA #94-01 - 8/13/01, "DETENTION WITHOUT PHYSICAL EXAMINATION OF NONCERTIFIED
TELEVISION RECEIVERS," Attachment 4/27/95
NOTE: This revision is being issued to revise the alert into the current
format and terminology. Changes are bracketed by asterisks (***).
TYPE OF
ALERT: *** Detention Without Physical Examination (DWPE)
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. ***
PRODUCT: Noncertified Multisystem Television Receivers
PRODUCT
CODE: 94V[][]07
PROBLEM: Violates the Radiation Control for Health and Safety Act
PAF CODE: PER (Performance)
PAC: *** 86007A ***
COUNTRY: See attachment
MANUFACTURER/
SHIPPER
ID: See attachment
IMPORTER'S
ID#: See attachment
CHARGE: "The article is subject to refusal of admission pursuant to
Section 536 of the Federal Food, Drug, and Cosmetic Act,(FD&C Act)
Electronic Radiation Control Provisions, in that it appears to not
comply with the requirements of 21 CFR 1020.10."
NOTE: Warning letters to importers may also cite the
prohibited acts identified in Section 538 of the FD&C Act.
OASIS CHARGE
CODE: No Tag
RECOMMENDING
OFFICE: CDRH, OC (HFZ-300)
REASON FOR
ALERT: CDRH is in receipt of numerous complaints of importers attempting
to import uncertified and illegal multisystem television
receivers. In addition, information has been received which
suggests that these importers may be submitting false Customs
and/or FDA import documents asserting that the merchandise
consists of "electronic goods, radios, stereos, etc.," or falsely
stating that the receivers are certified. The actual products may
have "certification" labels that were not applied by the foreign
firm or serial numbers and other identification information that
may have been removed or replaced.
Television receivers introduced into U.S. commerce are subject to
the Federal performance standard. Importers previously had been
allowed to import certain noncertified receivers that were
designated CCIR (Consultative Committee for International Radio)
Standard 220 Volt receivers. Because these products originally
would not accept the U.S. broadcast signal, and could not be
readily used in the U.S., the policy was established that these
products did not meet the applicability statement in the standard.
Later as technology progressed, products known as "multisystem"
televisions, which operate on either 220v or 120v electrical
supplies, became available. Some models would accept the U.S.
broadcast signals, and were determined to be subject to the
standard and had to be distinguished from other multisystem
receivers and detained.
Currently, all multisystem television receivers are considered
capable of operating in the U.S. Such receivers offered for sale
in the U.S. must be certified as meeting the performance standard
and meet all other regulations applicable to television receivers
before admission into the U.S.
***
GUIDANCE: Districts may detain without physical examination all shipments of
uncertified television receivers from the importers identified on
the attachment for this alert.
The attachment contains a list of importers who appear to be
improperly entering multisystem television receivers. In
addition, CDRH maintains a list of importers and foreign
manufacturers believed to be involved in the importation of
illegal television receivers as part of the IMPORTS.MASTER
computer program available through the Parklawn Computer Canter
(PCC) M204 database system. Instructions are available from HFZ-
343 and new accounts must be obtained from HFZ-307.
For questions or issues concerning science, science policy, sample
collection, analysis, preparation, or analytical methodology ,
contact the Division of Field Science at (301) 827-7605. ***
PRIORITIZATION
GUIDANCE: N/A
FOI: Purging between ^ ^ is required.
KEYWORDS: Television receivers, multisystem, CCIR, noncertified, import for
export, uncertified
PREPARED
BY: Ted Poplawski, DIOP (301) 443-6553.
DATE LOADED
INTO FIARS:
Attachment IA#94-01 April 27, 1995
IMPORTERS ILLEGALLY IMPORTING NON-CERTIFIED MULTI-SYSTEM T.V.
ILLEGALLY
IMPORTER ADDRESS
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- Model KV-2965
- Model KV-2565
MFR: Sony Corporation
7-35 Kitashinagawa 6 Chome
Tokyo, Japan,
OR Sony International, Ltd.
10 Hoe Chiang Road
Singapore
OR Sony TV Industries
Lot 4, Jalan F/1 Kawasan
Perindustrian Bangi, Bandar Bara
4300 Kajang
Selansor Darul Elisan
Malaysia
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