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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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IFC International 15-Sep-05

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Chicago District
55o West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863


 

September 15, 2005

WARNING LETTER
CHI-12-05

VIA FEDERAI, EXPRESS

Ms. Ildiko Carter, President
IFC International
412 Butterfly Road
Bolingbrook, Illinois 60490

Dear Ms. Carter:

We are writing to you because on April 19 - 20, 2005, an investigator from the Food and Drug Administration (FDA) collected information that revealed a serious regulatory problem involving the product known as "Arianna® BABY-Vac™ Nasal Vacuum," which is imported and marketed by your firm.

Under a United States law, the Federal Food, Drug, and Cosmetic Act (the Act), this product is considered to be a medical device because it is used to diagnose or treat a medical condition. The law requires that manufacturers of medical devices obtain marketing clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that newly introduced medical devices are safe and effective or substantially equivalent to other devices already legally marketed in this country.

Our records do not show that you obtained marketing clearance before you began offering your product For sale. The kind of information you need to submit in order to obtain this clearance is described on FDA's device web site at www.fda.gov/cdrh/devadvice. FDA will evaluate this information and decide whether your product may be legally marketed.

Because you do not have marketing clearance from the FDA, marketing your product is a violation of the law. In legal terms, the product is adulterated under section 501(f)(1)(B) [21 U.S.C. 351(f)(1){B)], and misbranded under section 502(0) of the Act [21 U.S.C. 352(0). Your product is misbranded under the Act because you did not submit a section 510(k} premarket notification, which is required by 21 U.S.C. 360(k), that shows your device is substantially equivalent to other devices that are legally marketed. Until you submit a section 510(k) premarket notification and FDA reviews it and notifies you that you may market your device, your product is 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)]

Additionally, your device was not included in a list required by section 510(j) [21 U.S.C. 360(j)] which is also a violation of section 502(0) of the Act [21 U.S.C. 352(0)]. During the April, 2005 inspection, you told the FDA inspector that your product does not require FDA premarket review because it is exempt from section 510(k) premarket notification requirements under 21 CFR 880.6740, which classifies the "vacuum-powered body fluid suction apparatus" as a class II device that is exempt from premarket notification procedures.

Even if your device would ordinarily be exempt from the premarket notification requirement, it is only exempt "to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type." 21 CFR 880.9. A manufacturer of a device that would ordinarily be exempt must submit a 510(k) premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when "the device is intended for a use different from the intended use of a legally marketed device; e.g., the device is intended for a different medical purpose or the device is intended for lay use where the former intended use was by health care professionals only," (21 CFR 880.9(a)) Your device has different characteristics than commercially distributed devices within this generic type. The commercially distributed devices are wall vacuum-powered devices used in a hospital or other professional health care setting. Your device is intended for home use with a household vacuum cleaner. Furthermore, the commercially distributed devices within this generic type are for health care professional use only whereas your device is intended for lay use. As a result, you must submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the "Arianna® BABY- Vac™ Nasal Vacuum."

The Arianna® BABY-Vac™ Nasal Vacuum is also misbranded under section 502(a) of the Act [21 U.S.C. 352(a)] in that your Internet web site, www.ifeintl.com,states that the Arianna® BABY-Vac™ Nasal Vacuum is "FDA Registered", which is false or misleading in accordance with 21 CFR 807.39, because this statement creates an impression of official approval of your product due to registration of the device establishment or possession of a registration number for the device establishment. Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products.

The above-stated inspection also revealed that your devices are misbranded under section 502(t)(2) of the Act [21 U.S.C. 352(t)(2)], in that your firm failed to furnish any material or information required by or under section 519 [21 U.S.C. 360i] respecting the device, by failing to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17.

You should know that these serious violations of the law may result in FDA taking regulatory action without further notice to you. These actions include, but are not limited to, seizing your product inventory, obtaining a court injunction against further marketing of the product, or assessing 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.

It is necessary to take action on this matter now. Please let this office know in writing what steps you have taken to correct the problem within 15 working days from the date you received this letter. We also ask that you explain how you plan to prevent this from happening again. If you need more time, let us know why and when you expect to complete your correction.

Please direct your response to Michael Lang, Compliance Officer, Food and Drug Administration, 550 West Jackson Blvd., 15th Floor, Chicago, IL, 60661-5716. If you have any questions about the contents of this letter please contact Mr. Lang at (312) 596-4225.

Sincerely,

/S/

Scott J. MacIntire
District Office

cc: President
OBED-EDOM KFT
1146. Budapest
AJTOSI DURER SDR 35
Hungary

President
ILLES CSOK ES TSA BT
TAPIOBICSKE U 21
Budapest 1173
Hungary