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
Dear Mr. 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 Food and Drug Administration (FDA)
revealed a serious regulatory problem involving the product known as the
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.
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.
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. 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.
Our records do not show that there is marketing clearance or approval in
effect for the 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. These Acupoint
Treasures were declared as "TIANSHI ACUPOINT TRESURE MASSAGE" with
product code "89I{}{}SA" under entry number FN5-0105653-8. The
inaccurate declaration on the entry caused these unapproved medical
devices to enter the United States without review by the FDA. Two
hundred of these devices were subsequently exported to Canada.
Because the Acupoint Treasure medical devices do not have marketing
clearance or approval from the FDA, they violate United States law. 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. Your devices are misbranded under the Act
because you did not submit a premarket notification under section 510(k)
of the Act. 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. 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)).
Until these serious violations of the Act are corrected, future
shipments of the Acupoiut Treasure may be refused admission to the
United States. This serious violation of the law may also result in FDA
taking regulatory action without further notice, including seizing your
product inventory. 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.
You should take prompt action to correct this deficiency. You should
notify this office within fifteen (15) working days from receipt 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. If corrective action cannot be
completed within 15 working days, state the reason for the delay and the
time within which the corrections will be completed.
Finally, you should understand that there are many FDA requirements
pertaining to the manufacture and marketing of medical devices. This
letter pertains only to the issue of premarket review requirements for
your device and does not necessarily address other obligations you have
under the law. 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. The FDA will evaluate
this information and decide whether your product may be legally
marketed. 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.
Please send your reply to the Food and Drug Administration, Attention:
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.
Sincerely,
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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