| Public Health Service Food and Drug Administration |
| Kansas City District Southwest Region 11630 West 80 Street Lenexa, Kansas 66214-3340 Telephone: (913) 752-2100 |
Department of Health and Human ServicesDecember 22, 2010
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
Ref. KAN 2011-03
Mark S. Patterson, President
Heritage Labs International LLC
560 N. Rogers Road
Olathe, Kansas 66062
Dear Mr. Patterson:
During an inspection of your firm located in Olathe, Kansas on June 15 through June 23, 2010, Investigator(s) from the United States Food and Drug Administration (FDA) determined that your firm manufactures In-Vitro Diagnostic Devices (IVD's) including the Appraise® Biometric Collection Tests for Hemoglobin Ale, Microalbumin, Prostate Specific Antigen, Thyroid Stimulating Hormone and Lipids. 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.
This inspection revealed that the Appraise® Biometric Collection Tests for Hemoglobin A1c, Microalbumin, PSA and TSH are 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 Code of Federal Regulations (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.
This inspection also revealed that the Appraise® Biometric Collection Tests for Hemoglobin A1c, Microalbumin, PSA and TSH are adulterated within the meaning of section 501 (f)(1)(B) [21 U.S.C. 351(f)(1)(B)] because you do not have in effect an approved application for premarket approval. Our inspection also revealed that the Appraise® Biometric Collection Tests for Prostate Specific Antigen (PSA), Thyroid Stimulating Hormone (TSH), Microalbumin and Lipids are misbranded under section 502(0) of the Act [21 U.S.C. 352(o)] because at the time of registration you did not include these devices in the listing of all devices manufactured by your firm.
Our inspection also revealed that your devices are misbranded under Section 502(a) of the Act [21 U.S.C. 352(a)] and within the meaning of 21 CFR 807.39. Your website (b)(4) displays a large banner which states "FDA Registered" which creates an impression of official approval of your establishment or its products.
We acknowledge the receipt of your July 15, 2010, response to the FDA 483 issued during the June 2010 inspection. These responses were related to the quality system deficiencies noted during the inspection and are not related to the contents of this warning letter. Your letter will be made part of our official permanent records for your firm. You must adequately implement and maintain each corrective action to ensure its effectiveness. Your corrective actions will be assessed during a further inspection. This acknowledgement is not an endorsement of the current operating conditions within your firm.
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 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: Matthew A. Walburger, Compliance Officer, at the address above. If there are questions regarding the content of this letter please contact Mr. Walburger at (913)752-2104.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation(s) noted in this letter and in the Inspectional Observations, Form FDA 483 (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 violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.
Sincerely,
/S/
John W. Thorsky
District Director
Kansas City District
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