Inspections, Compliance, Enforcement, and Criminal Investigations
Michigan Medical Innovations - Close Out Letter 6/6/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Detroit District Office|
300 River Place, Suite 5900
Detroit, MI 48207
Telephone: (313) 393-8100
Fax (313) 393-8139
June 6, 2013
Robert F. Kraal, President
Michigan Medical Innovations LLC.
481 Pettis Ave
Ada, MI 49301
Dear Mr. Kraal:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to the Warning Letter we issued to you on June 5, 2012. Based on our evaluation, you have discontinued manufacturing the DVT Care CA5 Portable Leg Compression Device that was the subject of the FDA Warning Letter. Additionally, in November 2012, your firm's FDA registration was amended to indicate you are no longer a medical device manufacturer.
If your firm decides to resume medical device manufacturing, you must submit registration and/or listing information within 30 days of beginning manufacturing activities. Also, if your device requires premarket notification clearance or approval, you must wait until your premarket submission [510(k), PMA, etc.] is cleared or approved to register your establishment and list the device. Additional information regarding medical device registration can be found at www.fda.gov.
CDR Kimberly Martin
Compliance Officer, Detroit District