Inspections, Compliance, Enforcement, and Criminal Investigations
Omega Laboratories Inc. 02/09/2009
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2771
February 9, 2009
VIA FEDERAL EXPRESS
John C. Vitullo
Omega Laboratories, Inc.
400 North Cleveland Avenue
Mogadore, OH 44260
Dear Mr. Vitullo:
Based on a recent review of your website at www.omegalabs.net and an inspection of your firm located in Mogadore, Ohio from February 14 through March 4, 2008, the United States (U.S.) Food and Drug Administration (FDA) has determined that your firm is marketing in the U.S. over-the-counter (OTC) test sample collection systems for drugs of abuse testing, specifically OTC test sample collection systems intended to collect hair samples outside of a medical setting and not on order of a health care provider so that these hair samples can be transported to a laboratory and tested using the ELISA (Enzyme Immuno-Assay) method for the presence of the following drugs of abuse or their metabolites: amphetamines, opiates, phencyclidine (PCP), and marijuana (carboxy-THC). FDA has determined that you are marketing these OTC test sample collection systems without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
Under section 201(h) of the Act, 21 U.S.C. 321(h), these test sample collection systems 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. The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.
A review of our records reveals that you have not obtained marketing approval or clearance before you began offering your products for sale, which is a violation of the law. Specifically, the above-referenced test sample collection systems are 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 devices are also misbranded under section 502(o) of 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.htm1. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
Please note that although the above-referenced test sample collection systems fall within the scope of 21 C.F.R. § 864.3260(a), they are not 510(k)-exempt under 21 C.F.R. § 864.3260(b) because they are not used in accordance with the restrictions set forth in 21 C.F.R. § 809.40. Specifically, the ELISA testing method used on the collected samples is not approved, cleared, or otherwise recognized by the FDA as accurate and reliable for the testing of hair specimens for the presence of the following drugs of abuse or their metabolites: amphetamines, opiates, phencyclidine (PCP), and marijuana (carboxy-THC). See 21 CFR § 809.40 for additional restrictions on the sale, distribution, and use of OTC test sample collection systems for drugs of abuse testing.
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. Finally, you should understand that there are many FDA requirements pertaining to the manufacture and marketing of devices. This letter pertains only to the issue of premarket review for your device and does not necessarily address other obligations you have under the law.
Teresa C. Thompson