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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