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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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AmeriWater, Inc. 10-Apr-07

Department of Health and Human Services

Public Health Service
Food and Drug Administration

Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2771

April 10, 2007



James W. Baker
AmeriWater, Inc.
1303 Stanley Avenue
Dayton, OH 45404

Dear Mr. Baker:

During an inspection of your firm located in Dayton, Ohio on November 7 through December 13, 2006, an investigator from the United States Food and Drug Administration (FDA) determine that your firm manufactures the Ozone Disinfection System used in hemodialysis for disinfection of the bicarbonate and water systems. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act the Act), 21 U.S.C. 321(h), this product is a 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.

This inspection revealed that the Ozone Disinfection System is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do 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 (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device 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) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the Agency. 21 C.F.R. 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.

The Ozone Disinfection System is further misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), in that the device was not included in a list required by section 510(j), 21 U.S.C. 360(j).

We have reviewed a response from Brian R. Bowman, Quality Manager, dated January, 2007, concerning observation number 1 noted on the Form FDA 483, Inspectional Observations (FDA 483). The response states that you have discontinued marketing the Ozone Disinfection System until you have obtained marketing clearance from the FDA. The response further indicates that you are preparing your premarket notification submission and plan to complete the submittal process by February 16, 2007. As of April 9, 2007, the FDA has not received your premarket notification.

It should be noted that this is the second time that FDA found your firm distributing medical devices without marketing clearance. An FDA inspection of your firm, in March 2002, revealed that you manufactured and distributed a chemical feed system without prior 510(k) clearance. After the inspection, your firm applied for and obtained appropriate clearance. Your firm also markets other devices that have received appropriate premarket clearance. This indicates that you a aware of premarket notification requirements for medical devices and knew or should have known that it was illegal to distribute a device without first obtaining FDA clearance.

You should 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 Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all 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 (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. 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.

Your response should be sent to Ms. Gina Brackett, Compliance Officer, Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about the content of this letter please contact Ms. Brackett at (513) 679-2700, ext. 167, or you may forward a fax to her at (513) 679-2773.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the FDA 483, issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.

Sincerely yours,


Carol A. Heppe
District Director
Cincinnati District