| Public Health Service Food and Drug Administration |
| 10903 New Hampshire Ave. Silver Spring, MD 20993-0002 |
Department of Health and Human ServicesWARNING LETTER
March 17, 2010
VIA FEDERAL EXPRESS
James P. Johnston, CO
James P. Johnston, CO, dba Midwest Ocular Prosthetics
450 Saint John Rd
Michigan City, IN 46360-7336
Dear Mr. Johnston:
During an inspection of your firm located in Michigan City, IN on May 1, 2009, investigator(s) from the United States Food and Drug Administration (FDA) determined that your firm manufacture artificial eyes and scleral shells. 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 are intended to affect the structure or function of the body.
Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means (section 510(p) of the Act (21 U.S.C. 360(p)) during the period beginning October 1st and ending on December 31st of each year. Our records indicate that you have not fulfilled your annual registration and listing requirements between October 1 and December 31 of 2008, and as of March 17, 2010, the firm has still not completed its required annual registration.
Therefore all of your devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(o)), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510, 21 U.S.C. § 360 and were not included in a list required by section 510(j), 21 U.S.C. § 360(j);
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) 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 violation(s), or similar violation(s), from occurring again. Include documentation of the corrective action you have taken. 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.
Information about device establishment registration and listing requirements can be found
on our website at: http://www.fda.gov/deviceregistrationandlisting/
Your response should be sent to:
David Racine
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
10903 New Hampshire Avenue
W066 Room 2621
Silver Spring, MD 20993-0002
If you have any questions about the content of this letter please contact: David Racine at 301-796-5777.
Sincerely,
/s/
Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and Radiological Health
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