Inspections, Compliance, Enforcement, and Criminal Investigations
Express Diagnostics Int'l., Inc 3-12-2009
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7133
FAX: (612) 334-4142
March 12, 2009
RETURN RECEIPT REQUESTED
Refer to MIN 09 - 12
Carolyn J. Cooper
Express Diagnostics International, Inc.
3279 Seventh Avenue, Suite 100
Marion, Iowa 52302
Dear Ms. Cooper:
As a result of an inspection of your firm located in Blue Earth, Minnesota, on October 28-29, 2008, the United States Food and Drug Administration (FDA) has determined that your firm is marketing DrugCheck® drug of abuse tests 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 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. The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from 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 did not obtain marketing approval or clearance before you began offering your product for sale, which is a violation of the law." Specifically, the DrugCheck® drug of abuse tests 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 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. [Title 21, Code of Federal Regulations (21 CFR), 21 CFR 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.
During the inspection, you claimed that your DrugCheck@ devices are covered by a 510(k) premarket clearance that was obtained by another firm. Certain distributors and repackagers are exempt from the 510(k) requirement if the device is covered under someone else's 510(k), as long as, they do not change the device's labeling (except for placing their, own name on it) or otherwise affect the device. See 21 CFR 807.85(b). Because your firm changes the labeling of the test strips that it purchases from the other firm and conducts manufacturing activities that otherwise affect these devices, your firm does not meet the requirements for this exemption.
Under 21 CFR 807.81(a)(3)(i) a new 510(k) is required when a device is changed or modified in a manner that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Your firm's manufacturing/assembly process, which includes [(b)(4)] that you purchase from the other firm, [(b)(4)] and packaging, labeling, testing, and storing the device before shipment, significantly modifies the cleared device in a manner that could significantly affect its safety or effectiveness. Thus, a new 510(k) premarket clearance is required.
You should take prompt action to correct the violation addressed in this letter. Failure to promptly correct this violation 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 15 working days from the date you receive this letter of the specific steps you have taken to correct the noted violation, including an explanation of how you plan to prevent this violation, or similar violations, 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.
Your response should be sent to Timothy G. Philips, Compliance Officer, at the address on this letterhead. If you have any questions about the content of this letter please contact Mr. Philips at (612) 758-7133.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. 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.
W. Charles Becoat
xc: Paul K. Johnson
VP and Managing Partner
Express Diagnostics International, Inc.
1550 Industrial Drive
Blue Earth, MN 56013