Interlectric Corp 4/13/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||900 U.S. Customhouse|
2nd and Chestnut Streets
Philadelphia, PA 19106
RETURN RECEIPT REQUESTED
April 13, 2012
Steven A. Rothenberg
1401 Lexington Avenue
Warren, Pennsylvania 16365
Dear Mr. Rothenberg:
During an inspection of your facility located at 1401 Lexington Avenue, Warren, Pennsylvania,on November 15, 2011, and December 6, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the RV620, a linear fluorescent “red” lamp device. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(h)], this product is a device, because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.
In a letter dated August 18, 2011, FDA responded to your firm’s request for information letter under Section 513(g) [21 U.S.C. 360c (g)] dated July 25, 2011, and determined that your firm’s RV620 devices require premarket notification and clearance. Your firm was also informed that your RV620 lamp is a Class II type device and that you may not market this device until your firm receives 510(k) clearance. During the inspection, FDA learned that your firm continues to manufacture and distribute the RV620 device in the United States without the required marketing clearance or approval, in violation of the Act.
A review of our records reveals that you did not obtain marketing approval or clearance before you began offering these devices for sale, which is a violation of the law. Therefore, the RV620 deviceis adulterated under section 501(f)(1)(B) of the Act [21 U.S.C. § 351(f)(1)(B)], because your firm does 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 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 your firm did not notify the agency of its 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) is deemed satisfied when a PMA is pending before the agency [21 CFR 807.81(b)]. The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html
. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
We reviewed your firm’s response dated December 14, 2011, and conclude that it is not adequate. Your firm stated that it was in the process of preparing a premarket notification submission, but will continue to market the RV620. Additionally, your firm stated that it has ceased sending literature that noted studies, that suggest that the spectrum produced by this lamp reduces wrinkles, and in your opinion was not a medical claim. There was no mention of a corrective action for distributed RV60 lamps containing the literature.
Your firm 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 the 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 the issuance of 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 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or 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. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to: Kirk D. Sooter, District Director, Room 901 U.S. Customhouse, Philadelphia, Pennsylvania, 19106-2973. If you have any questions about the content of this letter please contact: Richard C. Cherry, Compliance Officer, at (215) 717-3075 (phone)or (215) 597-8212 (fax).
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. 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.
Kirk D. Sooter