Tan Extreme Inc 2/8/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Chicago District|
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
February 8, 2013
Via UPS Next Day
Nimesh H. Patel, CEO
Tan Extreme, Inc. and L.A. Tan, Inc.
3775 West Arthur Ave.
Lincolnwood, IL 60712
Dear Mr. Patel:
During an inspection of your firm located at 3775 West Arthur Ave., Lincolnwood, IL, on July 27, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm marketed and distributed seven (7) sun tanning devices that you imported from (b)(4). Under Section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act), 21 USC 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 any function of the body.
Our inspection revealed that you have sold and distributed all seven (7) units advertised as “42 Collagen BodyWave.” These devices are labeled as total body anti-ageing with anticell/slimming/toning options from the Beauty Vibro Plate Plus programs. Also the “42 Collagen BodyWave” is being promoted as having new technologies for skin rejuvenation. These devices are labeled as “VANITY SUN + SLIM 180W 240W 3PHASE 60HZ ATTRACTION” sun tanning devices.
A review of our records reveals that you did not obtain clearance or approval before offering these devices for sale. Therefore, the sun tanning devices are adulterated under Section 501 (f)(1)(B) of the Act [USC 351 (f)(1)(B)], because your firm does not have an approved application for premarketing approval (PMA) in effect pursuant to Section 515(a) of the Act [21 USC 360(e)(a)], or an approved application for an investigational device exemption (IDE) under 520(g) of the Act [21 USC 360(j)(g)]. The devices are also misbranded under Section 502(o) of the Act USC 352(o), because you did not notify the Agency of your intent to introduce the devices into commercial distribution, as required by Section 510(k) of the Act, 21 [USC 360(k)]. For a device requiring premarket approval, the notification required by Section 510(k) is deemed satisfied when a PMA is pending before the Agency [21 CFR 807.81(b)]. The kind of information your firm needs to submit in order to obtain approval or clearance for the device is described on the internet at www.fda.gov/cdrh. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
On October 2, 2012 you attended a meeting in the Chicago District Office regarding your imported “VANITY SUN + SLIM 180W 240W 3PHASE 60HZ ATTRACTION” sun tanning devices. During the meeting you were informed of the need to take the seven (7) distributed sun tanning devices off the market and to apply for premarket approval (PMA). As of the date of this letter we are unaware that the devices have been removed from commercial distribution.
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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of issuance of the Warning Letter so that they may take this information into account when considering the award of contracts.
Given the serious nature of the violations of the Act, these tanning booths manufactured by (b)(4) 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, these products will remain on "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you if your firm’s response appears to be adequate, and we may need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
Please notify this office with in fifteen (15) business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, or similar violations, from occurring again. Include documentation of the corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. You firm’s response should be comprehensive and address all violation included in this Warning Letter.
Your response should be sent to: Matthew Sienko, Compliance Officer, U.S. Food and Drug Administration, 550 W. Jackson Blvd., 15th Floor, Chicago, IL 60661. Refer to the Unique Identification Number (CMS case # 382519). If you have any questions about the content of this letter, please contact Mr. Sienko at 312-596-4213 or via email at email@example.com.
Finally, you should know that this letter is not intended to be an all-inclusive list of violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Scott J. MacIntire
Quadra Medical S.r.l.
STR Com Cartigliana
143 B Bassano Del
Grappabassano Del Grappa
Quadra Medical S.r.l.
Via Nardi 98 Romano D’Ezzelino