Kemaren udah dibilang jangan diteruskan,...kok masih aja....
Mohon diperhatikan juga...
Heran deh,...
On 6/5/08, Melly Kristina <[EMAIL PROTECTED]> wrote:
>
> Maaf BA'ers untuk yang terakhir (soalnya ada translatenya biar kita ngga
> salah paham).
>
> berdasarkan translate di bawah..menurut saya yang di warning itu adalah
> sebuah alat medis (mungkin disini seperti alat BEKAM atau Akupunktur). jadi
> bukan tianshi kalsium.
> Mohon untuk diperhatikan lagi sebelum memforward suatu statement.
> Terima kasih.
>
> Pada 4 Juni 2008 09:27, Meliana Kristina Siregar <[EMAIL PROTECTED]>
> menulis:
>
> >
> >
> >
> >
> > *Subject:* RE: [balita-anda] Fwd: [sehat] warning dari FDA utk MLM
> > suplemen
> >
> >
> >
> > translates:
> >
> >
> >
> > Dear Mr. Campbell:
> >
> > =E8 Yth. Tuan Campbell
> >
> > An inspection conducted at your facility at Tianshi Health Products,
> > Inc., USA, 917 134th Street Southwest, Suite #A-8, Everett, Washington,
> > on February 19-20, 2004, by the
> > revealed a serious regulatory problem involving the product known as the
> > Acupoint Treasure.
> >
> > =E8 Pemeriksaan yang dilaksanakan pada pabrik anda Tianshi health
> > Products, Inc., USA, 917 134th Street Southwest, Suite #A-8, Everett,
> > Washington, pada tanggal 19 Februari 2004 oleh Food and Drug
> Administrati=
> on
> > (FDA) menemukan masalah pengaturan serius yang melibatkan produk dengan
> n=
> ama
> > Acupoint Treasure.
> >
> >
> >
> > Under a United States federal law, the Federal Food,
> > Drug, and Cosmetic Act (the Act), this product is a medical device
> > because it is intended for use in the diagnosis of disease or other
> > conditions or in the cure, mitigation, treatment or prevention of
> > disease, or is intended to affect the structure or function of the body.
> >
> > =E8 Menurut UU Federal Amerika & UU Makanan, Obat & Kosmetik, produk
> > tersebut merupakan alat medis karena dimaksudkan untuk dipergunakan dalam
> > diagnosa atau kondisi lainnya atau dalam pengobatan,
> pengurangan/peredaan=
> ,
> > perawatan atau pencegahan penyakit, atau dimaksudkan untuk mempengaruhi
> > struktur maupaun fungsi tubuh.
> >
> >
> >
> > See section 201(h) of the Act, 21 USC. 321 (h). Specifically, according
> > to its labeling, the Acupoint Treasure is a "pocket medical acupuncture
> > appliance" that claims to lower blood pressure, eliminate inflammation,
> > relieve pain, improve microcirculation, and treat diseases, including
> > periarthritis of humeroscapularis, headache, waist pain, and nerve pain.
> >
> > =E8 Pada bagian 201(h) UU, 21 USC. 321 (h). Secara spesifik, menurut
> > labelnya, Acupoint Treasure adalah "peralatan saku untuk akupuntur medis"
> > yang diklaim dapat menurunkan tekanan darah, menghilangkan peradangan,
> > mengurangi rasa sakit, meningkatkan sirkulasi mikro (peredaran darah) dan
> > perawatan penyakit, termasuk rematik, sakit kepala, sakit pinggang &
> nyer=
> i
> > syaraf.
> >
> >
> > The law requires that manufacturers of certain medical devices or
> > initial importers of certain foreign-made medical devices obtain
> > marketing approval or clearance for their products from FDA before they
> > may offer them for sale or import them into the United States.
> >
> > =E8 Hukum menyatakan bahwa produsen alat2 medis tertentu atau importir
> > utama alat2 medis impor tertentu perlu memperoleh persetujuan atau izin
> > pemasaran untuk produk mereka dari FDA sebelum mereka dapat menawarkan
> da=
> lam
> > penjualan atau impor ke Amerika Serikat.
> >
> >
> >
> > This helps to protect the public health by ensuring that new medical
> > devices
> > are shown to be either safe and effective or substantially equivalent to
> > other devices already legally marketed in this country.
> >
> > =E8 Ini akan membantu melindungi kesehatan masyarakat dengan
> memastika=
> n
> > bahwa alat2 medis baru dibuktikan aman dan/atau efektif atau secara umum
> > sebanding dengan alat2 lainnya yang telah dipasarkan secara resmi di
> nega=
> ra
> > ini.
> >
> >
> > Our records do not show that there is marketing clearance or approval in
> > effect for the Acupoint Treasure.
> >
> > =E8 Catatan kami tidak menunjukkan bahwa ada persetujuan atau izin
> > pemasaran yang berlaku untuk Acupoint Treasure.
> >
> >
> >
> > Our inspection revealed that 2000
> > Acupoint Treasures were nonetheless imported and delivered to your
> > Everett, Washington facility in August 2003 from your facility Tianjin
> > Tianshi Bioengineering Co., Ltd., Tianjin, China.
> >
> > =E8 Pemeriksaan kami menunjukkan bahwa 2000 buah Acupoint Treasures
> > diimpor dan/atau dikirim ke pabrik Anda di Everett, Washington pada
> Agust=
> us
> > 2003 dari pabrik Anda Tianjin Tianshi Bioengineering Co., Ltd., Tianjin,
> > China.
> >
> >
> >
> > These Acupoint Treasures were declared as "TIANSHI ACUPOINT TRESURE
> > MASSAGE" with
> > product code "89I{}{}SA" under entry number FN5-0105653-8.
> >
> > =E8 Acupoint Treasures ini dinyatakan sebagai "TIANSHI ACUPOINT
> TRESUR=
> E
> > MASSAGE" dengan kode produk "89I{}{}SA" dengan nomor catatan
> > FN5-0105653-8.
> >
> >
> >
> > The inaccurate declaration on the entry caused these unapproved medical
> > devices to enter the United States without review by the FDA.
> >
> > =E8 Pernyataan yang tidak tepat pada catatan telah menyebabkan alat
> me=
> dis
> > yang tidak disetujui ini masuk ke Amerika Serikat tanpa pemeriksaan FDA.
> >
> >
> >
> > Two hundred of these devices were subsequently exported to Canada.
> >
> > =E8 Dua ratus alat ini kemudian telah diekspor ke Kanada.
> >
> >
> > Because the Acupoint Treasure medical devices do not have marketing
> > clearance or approval from the FDA, they violate United States law.
> >
> > =E8 Karena alat medis Acupoint Treasure tidak memiliki persetujuan
> ata=
> u
> > izin pemasaran dari FDA, maka telah terjadi pelanggaran hukum Amerika
> > Serikat.
> >
> >
> >
> > In legal terms, the devices are misbranded under section 502(o) [ 21
> U.S.=
> C.
> > 352(o)] and adulterated under section 501(f)(1)(B) [ 21 U.S.C.
> > 351(f)(1)(B)] of the Act.
> >
> > =E8 Secara hukum, alat tersebut bermerek salah menurut UU bagian
> 502(o=
> ) [
> > 21 U.S.C. 352(o)] dan dipalsukan menurut bagian 501(f)(1)(B) [ 21 U.S.C.
> > 351(f)(1)(B)].
> >
> >
> >
> > Your devices are misbranded under the Act
> > because you did not submit a premarket notification under section 510(k)
> > of the Act.
> >
> > =E8 Alat anda bermerek salah menurut UU karena anda tidak menyerahkan
> > pemberitahuan pra-pemasaran menurut UU bagian 510(k).
> >
> >
> >
> > Until you submit a section 510(k) premarket notification and
> > FDA reviews it and notifies you that your device is substantially
> > equivalent to other legally marketed devices, your devices are also
> > adulterated under the Act because the law requires, and you do not have,
> > an approved premarket approval application that shows your device is
> > safe and effective.
> >
> > =E8 Sampai anda menyerahkan pemberitahuan pra-pemasaran sesuai UU
> bagi=
> an
> > 510(k) dan FDA memeriksanya dan memberitahukan anda bahwa alat anda
> secar=
> a
> > mendasar sebanding dengan alat2 lainnya yang telah dipasarkan secara
> resm=
> i,
> > alat anda juga termasuk palsu menurut UU karena hukum menyatakan, dan
> and=
> a
> > tidak memilikinya, permohonan persetujuan pra-pemasaran yang telah
> disetu=
> jui
> > yang menunjukkan bahwa alat anda aman & efektif.
> >
> >
> >
> > For a product requiring premarket approval before
> > marketing, the notification required by section 510(k) of the act is
> > deemed to be satisfied when a premarket approval application (PMA) is
> > pending before the agency (21 CFR 807.81 (b)).
> >
> > =E8 Untuk produk yang memerlukan persetujuan pra-pemasaran sebelum
> > dipasarkan, pemberitahuan menurut UU bagian 510(k) dipertimbangkan untuk
> > dipenuhi saat pemohonan persetujuan pra-pemasaran ditangguhkan pada agen
> =
> (21
> > CFR 807.81 (b)).
> >
> >
> > Until these serious violations of the Act are corrected, future
> > shipments of the Acupoiut Treasure may be refused admission to the
> > United States.
> >
> > =E8 Sampai pelanggaran serius terhadap UU ini diselesaikan, pengiriman
> > Acupoiut Treasure yang akan datang dapat ditolak izin masuknya ke Amerika
> > Serikat.
> >
> >
> >
> > This serious violation of the law may also result in FDA
> > taking regulatory action without further notice, including seizing your
> > product inventory.
> >
> > =E8 Pelanggaran hukum serius ini juga dapat berakibat FDA melakukan
> > tindakan pengaturan tanpa pemberitahuan lebih lanjut, termasuk menyita
> > inventaris produk.
> >
> >
> >
> > Federal agencies are informed of the issuance of ail
> > warning letters about drugs and medical devices so they may consider
> > this information when awarding government contracts.
> >
> > =E8 Kantor2 federal telah diberitahukan tentang dikeluarkannya surat
> > peringatan keras tentang obat2an dan alat2 medis, sehingga mereka dapat
> > mempertimbangkan info ini dalam menyelesaikan kontrak pemerintah.
> >
> >
> > You should take prompt action to correct this deficiency.
> >
> > =E8 Anda harus segera bertindak untuk memperbaiki kekurangan ini.
> >
> >
> >
> > You should notify this office within fifteen (15) working days from
> recei=
> pt
> > of this
> > letter of the specific steps you have taken to correct the noted
> > violations, including an explanation of each step taken to prevent the
> > recurrence of similar violations.
> >
> > =E8 Anda harus memberitahukan kami kembali dalam jangka waktu lima
> bel=
> as
> > (15) hari kerja sejak diterimanya surat ini beserta langkah2 spesifik
> yan=
> g
> > telah anda lakukan untuk memperbaiki pelanggaran tersebut di atas,
> termas=
> uk
> > penjelasan langkah2 yang dilakukan untuk mencegah pelanggaran serupa
> terj=
> adi
> > kembali.
> >
> >
> >
> > If corrective action cannot be completed within 15 working days, state
> th=
> e
> > reason for the delay and the
> > time within which the corrections will be completed.
> >
> > =E8 Jika langkah perbaikan tersebut tidak dapat diselesaikan dalam 15
> > hari kerja, cantumkan alasan tertundanya dan jadwal waktu penyelesaian
> > perbaikan.
> >
> >
> > Finally, you should understand that there are many FDA requirements
> > pertaining to the manufacture and marketing of medical devices.
> >
> > =E8 Terakhir, anda harus memahami bahwa banyak persyaratan FDA terkait
> > dengan produksi dan pemasaran alat2 medis.
> >
> >
> >
> > This letter pertains only to the issue of premarket review requirements
> f=
> or
> > your device and does not necessarily address other obligations you have
> > under the law.
> >
> > =E8 Surat ini hanya mencakup masalah persyaratan pemeriksaan
> > pra-pemasaran untuk alat anda dan secara tidak langsung kewajiban2 anda
> > lainnya berdasarkan hukum.
> >
> >
> >
> > The kind of information you need to submit in order to
> > obtain clearance or approval for your device is described on FDA's
> > Internet website at www.fda.gov/cdrh/devadvice.
> >
> > =E8 Jenis informasi yang perlu anda serahkan dalam rangka memperoleh
> > persetujuan atau izin untuk alat anda dijelaskan dalam website Internet
> F=
> DA
> > di www.fda.gov/cdrh/devadvice.
> >
> >
> >
> > The FDA will evaluate this information and decide whether your product
> ma=
> y
> > be legally
> > marketed.
> >
> > =E8 FDA akan mengevaluasi informasi ini dan memutuskan apakah produk
> a=
> nda
> > dapat dipasarkan secara resmi.
> >
> >
> >
> > You may obtain general information about all of FDA's
> > requirements for manufacturers and distributors of medical devices by
> > contacting our Division of Small Manufacturers and International
> > Consumer Assistance (DSMICA) at (800) 638-2041 or through the Internet
> > at http://www.fda.gov.
> >
> > =E8 Anda dapat memperoleh informasi umum tentang semua persyaratan FDA
> > untuk produsen dan distributor alat2 medis dengan menghubungi Division of
> > Small Manufacturers and International Consumer Assistance (DSMICA) telp.
> > (800) 638-2041 atau lewat Internet di http://www.fda.gov.
> >
> >
> > Please send your reply to the Food and Drug Administration, Attention:
> > Lisa M. Althar, Compliance Officer, 22201 23rd Drive SE, Bothell,
> > Washington 98021-4421.
> >
> > =E8 Kirimkan balasan anda ke FDA, A/n: Lisa M. Althar, Compliance
> > Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421.
> >
> >
> >
> > If you have questions regarding any issue in this
> > letter, please contact Lisa M. Althar at (425) 483-4940.
> >
> > =E8 Bila ada hal2 yang anda perlu tanyakan dalam surat ini, silahkan
> > hubungi Lisa M. Althar telp. (425) 483-4940.
> >
> >
> > Sincerely,
> >
> > =E8 Hormat kami,
> >
> >
> >
> > ---------- Forwarded message ----------
> > From: *Gopina Goham* <[EMAIL PROTECTED]>
> > Date: 2008/6/3
> > Subject: [balita-anda] Fwd: [sehat] warning dari FDA utk MLM suplemen
> > To: BA milis <balita-anda@balita-anda.com>
> >
> >
> > cross posting, mengenai tianshi. kalau memang sudah ada uji klinis,
> > kenapa sampai FDA memberi peringatan ya?
> >
> >
> > ---------- Forwarded message ----------
> > From: Apriyanti <[EMAIL PROTECTED]>
> > Date:
> > Mon, May 5, 2008 at 3:37 PM
> >
> > Subject: [sehat] warning dari FDA utk MLM suplemen
> > To: [EMAIL PROTECTED]
> >
> >
> >
> >
> >
> > Department of Health and Human Services' logoDepartment of Health
> > and Human Services
> >
> >
> >
> > Public Health Service
> > Food and Drug Administration
> >
> >
> >
> > Seattle District
> > Pacific Region
> > 22201 23rd Drive SE
> > Bothell, WA 98021-4421
> > Telephone: 425-486-8788
> > FAX: 425-483-4996
> >
> > May 7, 2004
> >
> > VIA CERTIFIED MAIL
> > RETURN RECEIPT REQUESTED
> >
> > In reply refer to warning Letter SEA 04-28
> >
> > Ian B. R. Campbell, General Manager
> > Tianshi Health Products, Inc., USA
> > 917 134th Street Southwest, Suite #A-8
> > Everett, Washington 98204
> >
> > WARNING LETTER
> >
> >
> > Charles M. Breen
> > District Director
> >
> > cc: Percy K. Chin, Chief Executive Officer
> > Tianjin Tianshi Bioengineering Company, Ltd.
> > Henderson Building
> > 18 Jianguomennei Avenue
> > Tower 1, Floor 20
> > Beijing, China 100005
> >
> > This page was posted on November 27, 2004.
> >
> > http://www.casewatch.org/fdawarning/prod/2004/tianshi.shtml
> >
> >
> > ------------------------------------
> >
> > =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
>
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> =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D
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> >
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> > --------------------------------------------------------------
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