ASI Medical, Inc. 1/23/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
January 23, 2013
VIA UNITED PARCEL SERVICE
Mr. John W. McPeek
ASI Medical, Inc.
14550 East Easter Avenue
Centennial, Colorado 80112
Dear Mr. McPeek:
During an inspection of your firm located in Centennial, Colorado, on December 19, 2011,through December 22, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Advance Dental Classic Series Dental Carts and the Advanced Dental Designer Series Dental Carts. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
We acknowledge that your firm submitted applications for clearance of the Advanced Dental Classic Series Dental Cart ((b)(4)) and the Advanced Dental Designer Series Dental Cart ((b)(4)) under section 510(k) of the Act, 21 U.S.C. § 360(k). (b)(4) Consequently, your firm does not have FDA marketing clearances for its Advance Model Dental Units, which your firm has been distributing since 2010.
These devices are therefore adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm
. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Your firm should immediately cease distribution of these devices and take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, Room 2609, 10903 New Hampshire Ave., Silver Spring, Maryland 20993. Refer to CMS case # 370803 when replying. If you have any questions about the contents of this letter, please contact: Ronald Swann, MS, at 301-796-5469.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. Your firm should investigate and take prompt actions to correct the violations noted in this letter and in the Inspectional Observations, Form FDA 483, issued at the close of the inspection.
Steven D. Silverman
Office of Compliance
Center for Devices and