Inspections, Compliance, Enforcement, and Criminal Investigations
IPCH Management, Inc
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|10903 New Hampshire Ave.
White Oak #66 - 4621
Silver Spring, MD 20903-0002
FEB 03 2010
VIA FEDEBAL EXPRESS
Ms. Pat Canipe
P.O. Box 3096
Sugar Land, Texas 77487-3096
Dear Ms. Canipe:
The Center for Devices and Radiological Health (CDRH) determined, as a result of reviewing our records and your company website, that your firm has failed to submit the required Radiation Safety Product Report for Tootsie Tanner Model 127661-4002 portable foot tanner as requested by our letter dated July 27, 2009. In addition, this letter is to advise you of items of noncompliance encountered during review of the user manual for the Tootsie Tanner at http://tootsietanner.com/products.asp
1. 21 CFR 1040.20 (d)(1)(i) The warning statement is not sufficient. There are four deficiencies. The following texts need corrections: "CAUSE PERMANENT AGING" should read, "CAUSE PREMATURE AGING"; "SENSITIVITY TO ULTRAVIOLET, should read, "SENSITIVITY TO THE ULTRAVIOLET"; and "CONSULT PHYSICIANS BEFORE" should read "CONSULT PHYSICIAN BEFORE". In addition, the statement, .....WEAR PROTECTIVE EYEWEAR....INJURY TO THE EYES." is not highlighted from the remainder of the warning statement as required.
2. 21 CFR 1040.20 (d)(3)(i) The product failed to provide a recommended exposure schedule that is legible and readily accessible to view by the person being exposed immediately before the use of the product. The exposure schedule is located on the rear panel of the sunlamp and is not readily visible to the user. Also the schedule is in white letters and has poor contrast against the light-colored rear panel.
3. 21 CFR 1040.20(e)(1) The manual for the portable foot tanner provided inadequate user instructions. Specifically, it indicates SKIN TYPE 4 may receive a maximum of 30 minutes of exposure time. However, the erythemal time (Te) is 20 minutes and this sets the limit for the maximum exposure time. Furthermore, to achieve the desired outcome, the user needs to reset the timer, which is considered hazardous to health from radiation over exposure. In addition, the maximum first-week exposure of 20 minutes for SKIN TYPE 2 in the schedule exceeds the First Week Max time (.75 MED) of3.8 minutes.
4. 21 CFR 1040.20(c)(2)(ii) The maximum timer interval may not exceed the maximum exposure time (Te), which is 20 minutes for this product. The timer goes to 30 minutes, thus the device exceeds the Te time by 10 minutes.
5. 21 CFR 1002.10 and 1002.11 require submission of a Radiation Safety Product Report or Product Report Supplement prior to introduction into commerce of any products that are subject to the performance standard for sunlamp products. 21 CFR 1002.13 requires submission of an annual report by your firm each year by September 1st covering the products produced during the 12 month period ending the preceding June 30th. Your firm failed to submit annual reports, supplemental reports, and initial product reports.
Section 538(a) of the Federal Food, Drug, and Cosmetic Act (the Act), Chapter V, Subchapter C, 21 U.S.C. § 360oo(a), prohibits any manufacturer from certifying or introducing into commerce sunlamp products which do not comply with the standard. This section also states it is unlawful for any manufacturer to fail to establish and maintain required records or to submit required reports. Failure to respond to this letter may be considered to be a violation of Section 538(a)(4) of the Act, 21 U.S.C. § 360oo(a)(4). The Food and Drug Administration (FDA) is prepared to invoke regulatory actions if you fail to comply with these requirements. These actions may include an injunction and/or imposition of civil penalties as provided for in Section 539 of the Act, 21 U.S.C. § 360pp. Persons failing to correct violations and/or continued violations of the Act are subject to civil penalties of up to $1,100 per violation and up to a maximum penalty of $355,000 without further notification by the FDA. In cases where a foreign manufacturer fails to respond, penalties may be imposed upon importers.
You must respond in writing within 15 working days of receipt of this letter to one of the options listed below. In your response, you must also provide the number of the referenced products which have been produced and the number of such products that have left the place of manufacture. In addition, if the product distribution was confined to specific geographical areas of the United States, please specify those areas.
1. Refutation - You may submit your views and evidence to establish that the alleged failures to comply do not exist.
2. Exemption Request - You may request an exemption from user and dealer/distributor notification and from obligation to correct the violative products. Your request must include the grounds upon which such exemption is requested (see 21 CFR 1003.30 and 1003.31).
3. Purchaser Notification and Corrective Action - If you neither refute the noncompliance nor request an exemption, then you must: (a) notify purchasers and dealers/distributors of the violative products as specified in 21 CFR 1003.10(b), and (b) submit a written corrective action plan (CAP) to fulfill your obligation under 21 CFR 1004.1 to repair, replace, or refund the cost of the violative products.
a. Notification Letter - Requirements for preparation of notification letters are prescribed in 21 CFR 1003.21 and 1003.22. A copy of the notification letter(s) sent to purchasers and dealers must also be sent to the FDA. It is recommended that you submit a draft of this letter to us for review.
b. Corrective Action Plan - Instructions for preparation of a CAP may be found in 21 CFR 1004.2, 1004.3, or 1004.4.
If you request additional time to prepare your refutation, notification, CAP, or evidence to support a requested exemption, you must provide the reasons for any delays and a reasonable target date for the full submission of your response. Be aware that if an acceptable CAP cannot be prepared promptly, you may be required to proceed with interim notification to affected persons as required by 21 CFR 1003.11 (c) and 1003.21. Therefore, you are encouraged to immediately begin your preparation of accurate user location lists.
When you have completed any production changes necessary to assure compliance of future units and you have submitted the required reports and report supplements, you may resume introduction of these products into commerce. Note, you must correct the noncompliance on all sold products with an approved CAP.
Your response should be sent to: Chief, Electronic Products Branch, Division of Mammography Quality and Radiation Programs, Office of Communication, Education, and Radiation Programs, Center for Devices and Radiological Health, 10903 New Hampshire Avenue, W066-4621, Silver Spring, MD 20993-0002. If you have further questions on these requirements, please contact LCDR Varsha B. Savalia of the Electronic Products Branch at (301) 796-5867.
Lynne L. Rice, Director
Office of Communication, Education,
and Radiation Programs
Center for Devices and Radiological Health