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 <[email protected]>
>
>
> 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
>
>
> ------------------------------------
>
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