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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Genetic Testing Institute, Incorporated 14-Nov-05

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration


Minneapolis District Office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
Telephone: (612) 758-7119
FAX: (612) 334-4142

November 14, 2005

Refer to MIN 06 - 14


James Tidey
Genetic Testing Institute, Incorporated
20925 Crossroads Circle, Suite 200
Waukesha, WI 53186-4054

Dear Mr. Tidey:

The Food and Drug Administration (FDA) conducted an inspection of your establishment, Genetic Testing Institute, Incorporated, located in Waukesha, Wisconsin, on July 14-20, 2005. During the inspection our investigators determined that the PF4 Enhanced ELISA kit marketed by your firm is a device as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act). The above stated inspection found that the device is adulterated under section 501(f}(1) (B) and 501(h) and misbranded under section 502(o) of the Act.

The inspection found that [redacted] was added to the diluent for alkaline phosphatase conjugates to increase stability. This change was not fully validated to ensure that it did not adversely affect the finished device, as required by Title 21, Code of Federal Regulations (21 CFR) 820.100(a)(4). During the inspection, you provided no documentation to demonstrate that the change was fully validated and a representative of your firm stated that such validation was not necessary. We acknowledge receipt of a letter dated August 14, 2005, with attachments from Leigh Anne Tidey, which responds to the Inspectional Observations Form FDA-483 issued at the conclusion of the inspection. After review of this response, we have the following comments. You stated that a substance was added to improve the shelf-life of the conjugate. Lot comparisons were presented as evidence that consideration of [redacted] was incorporated in your final evaluation. This does not show complete validation of the finished product over its shelf-life or explain discrepant values as reported by customers. The failure to fully validate the change causes the device to be adulterated under section 501(h) of the Act [21 U.S.C. 351(h)].

FDA cleared a premarket submission [510(k)] for this in vitro diagnostic assay kit in 1999 (K983379). The aforementioned addition of [redacted], is a change to the device that could significantly affect its safety or effectiveness and requires the submission of a 510(k) to FDA, 21 CFR 807.81(a)(3)(i). We have no record of receiving a 510(k) for this change to your product. Because you do not have marketing clearance from the FDA, marketing the changed product is a violation of the law. In legal terms, the product is adulterated under section 501(f) (1) (B), [21 U.S.C. § 351(f) (1)(B)], and misbranded under section 502(o) of the Act, [21 U.S.C.§ 352(o)]. Your product is misbranded under the Act because you did not submit a section 510(k) premarket notification, which is required by. 21 U.S.C § 360(k), that shows your device is substantially equivalent to other devices that are legally marketed. Until you submit a section 510(k) premarket notification and FDA reviews it and notifies you that you may market your device, your product. is also adulterated under the Act because the law requires, and you do not have, an approved premarket approval application that shows your device is safe and effective. For a product requiring premarket approval before marketing, the notification required by section 510(k) of the Act is deemed to be satisfied when a premarket approval application (PMA) is pending before the agency. 21 CFR§ 807.81(b).

This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. You also must promptly initiate permanent corrective and preventive action on your Quality System.

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. Additionally, no applications for premarket approval of Class III devices to which the Quality System/ GMP deficiencies are reasonably related will be approved until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be granted until the violations related to the subject devices have been corrected.

You should take prompt action to correct these deviations. Failure to promptly correct these deviations 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 penalties.

Please notify this office in writing within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure that similar violations will not recur. 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 Jane E. Nelson, Compliance Officer, Food and Drug Administration, 212 Third Avenue South, Minneapolis, Minnesota 55401.



W. Charles Becoat
Minneapolis District