Inspections, Compliance, Enforcement, and Criminal Investigations
Sallamander Concepts CC Pty Ltd 8/23/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Document Mail Center - WO66-0609
Silver Spring, MD 20993-0002
AUG 23 2010
VIA UPS EXPRESS
Dr. Michael A. Meyer
Sallamander Concepts CC Pty Ltd
320 The Hillside
Suite 11, 1st Floor, Rynlal Building
Box 14007, Hatfield, 0028 South Africa
Dear Dr. Meyer:
The Food and Drug Administration (FDA) has learned that your firm is marketing the Sanitoets' Malaria home test, Urine test strips, and Prostate test in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). 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.
Review of your internet websites: www.sallamanderconcepts.com/sanitoets.htm and www.anytestkits.com also revealed that the Sanitoets' Malaria home test, Urine test strips and Prostate home test 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). These devices are 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) nor were these devices manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510,21 U.S.C. 360; was not included in a list required by section 510(j), 21 U.S.C. 360(j); or a notice or other information respecting the device was not provided to the FDA as required by section 510(k), 21 U.S.C. 360(k).
For a device requiring premark et 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 available through 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.
Given the serious nature of the violation(s) of the Act, Sanitoets' Malaria home test, Urine test scripts and Prostate home test manufactured by your firm are subject to refusal of admission under section 801 (a) of the Act, 21 U.S.C. § 381 (a), in that they appear to be adulterated. As a result, FDA may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, you should provide a written response to this Warning Letter as described below and correct the violation(s) described in this letter. We will notify you if your response is adequate, and we may need to re-inspect your facility to verify that the appropriate corrections have been made.
Also, U.S. 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, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
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. Please provide a translation of documentation not in English to facilitate our review.
Your response should be sent to:
James L. Woods, WO66, Office 5688
Patient Safety and Product Quality
Office of In vitro Diagnostic Device Evaluation and Safety
10903 New Hampshire Avenue
Silver Spring, MD 20993
If you have any questions about the content of this letter please contact: Dainelle Clark at 301-796-6190.
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 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.
Alberto Gutierrez, Ph.D.
Office of Invitro Diagnostic Device
Evaluation and Safety
Center for Device and Radiological