Inspections, Compliance, Enforcement, and Criminal Investigations
Alliance Security Products, Inc. 14-Jan-04
Department of Health and Human Services
Public Health Service
Center for Devices and
RETURN RECEIPT REQUESTED
JAN 14 2004
Mr. Steven Baker
Alliance Security Products, Inc.
1 West Street, #3508
New York, New York 10004
Dear- Mr. Baker:
The Food and Drug Administration (FDA) has obtained information from your Internet website, http://www.store.yahoo.com/safetyproducts-store/sarsprotection.html, that reveals a serious regulatory problem involving the following: 3M N95 8511, 3M 8223 N140 Particulate Respirators, and the 3M Respirator Lv11 and Lv12; Affinity Plus, and Ultra respirators; Peace of Mind Kits which may contain N95 Affinity, N95 3M 8511 respirator, N100 3M8233 respirator or the N95 3M 8511 respirator, and an assortment of the following: personal hygiene kit, anti microbial hand wipes, anti-germicidal hand wipes, latex gloves, eye protection goggle, and nitrile latex free gloves. These products are commercially distributed by your firm.
Your web site recommends and suggests use of the above product for "S.A.R.S. Protection" and "the best equipment available for protection from the SARS virus, even if not yet proven effective by clinical studies or tests." Consequently, these products are intended for use in the cure, mitigation, treatment, or prevention of disease within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. 321(h), and is a medical device that is subject to the Act's requirements for premarket approval or clearance by FDA.
Our records do not show that approval or clearance has been obtained for the 3M N95 8511, 3M 8223 N100 Particulate respirators, 3M Respirator Lvl1 and Lvl2, Affinity Plus and Ultra respirators, the Peace of Mind Kits or for any of its components to prevent SARS transmission or for any other SARS-related indication. Accordingly, these products are adulterated under section 501 (f)(1)(B) of the Act (21 U.S.C. 351 (f)(1)(B)), in that they are class III devices under section 513(f)(21 U.S.C. 360c(f)) and you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) (21 U.S.C. 360e(a)) or an approved application for investigational device exemption under section 520(g) (21 U.S.C. 360j(g)). The products are also misbranded under section 502(o) (21 U.S.C. 352(o)), because a notice or other information respecting them was not provided to the FDA as required by section 510(k)(21 U.S.C. 360(k)). For a product requiring premarket approval (as opposed to clearance), the notification required by section 510(k) is deemed to be satisfied when a PMA is pending before the agency. 21 CFR 807.81(b).
This serious violation of the law may result in the FDA taking regulatory action without further notice to you. Such action can include, but is not limited to, seizing your product inventory, obtaining a court injunction against further marketing your products, or seeking civil money penalties. Also, Federal agencies are informed about the Warning Letters we issue, such as this one, so that they may consider this information when awarding government contracts.
Please respond in writing, within 15 days of receiving this letter, by explaining the specific steps you have taken to correct this violation and to assure that similar violations will not occur. If you need additional time, please explain the reason for the delay and advise us when you expect to respond. Also, we request that you provide us with the name and address of, and the name of a contact person for, the manufacturers of the medical latex gloves included in the kits.
Please address your response to Ms. Betty Collins, Director, Division of Enforcement A, Office of Compliance, Center for Devices and Radiological Health, Food and Drug Administration, 2098 Gaither Road (HFZ-320), Rockville, Maryland 20850. If you have any questions concerning the contents of this letter, you may contact Carolyn Niebauer, Chief, General Hospital Devices Branch, or Diane Goldsberry, Technical Information Specialist, by phone at (301) 594-4618 or by facsimile at (301) 594-4638.
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 clearance or approval for your devices and does not necessarily address other obligations you have under the Act. You may obtain general information about FDA requirements for medical devices by contacting our Division of Small Manufacturers, International and Consumer Assistance at 1-800-638-2041 or through the Internet at <http://www.fda.gov>.
Finally, in addition to the Act, you may be subject to the Federal Trade Commission Act, which is administered by the Federal Trade Commission (FTC). A copy of this letter is being forwarded to the FTC.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and