Inspections, Compliance, Enforcement, and Criminal Investigations
Solafeet, Inc 9/2/09
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
SEP - 2 2009
VIA FEDERAL EXPRESS
Mr. William I. Johnson
1657A West University Parkway
Sarasota, Florida 34243
Dear Mr. Johnson:
This letter is to advise you of items of noncompliance encountered during review of the Initial Product Report Submission [0910259-000]for the Solafeet portable foot tanner and your company website at http://solafeet.com/. The Food and Drug Administration (FDA) noted the following violations:
1. 21 CFR 1040.20 (d) (1) (iv). The product failed to have a label that contained a recommended exposure schedule including
duration and spacing of sequential exposures and maximum exposure times in minutes.
2. 21 CFR 1040.20(e) (1) (iii). The operator's manual for the portable foot tanner did not provide adequate instructions for the proper operation of the product including the function, use, and setting of the timer and other controls, and the use of protective eyewear. The operator's manual provided instructions for use, including calculated maximum exposure times (Te) and schedules based on skin type (determined by the device's erythemal time). However, the timer on the device permits the user to set it for an amount of time that is greater than the recommended Te, resulting in overexposure.
Section 538(a) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 USC 360oo(a)) prohibits any manufacturer from certifying or introducing into commerce sunlamp products which do not comply with the applicable standard. Sections 538(a) (3) and (a) (4) of the Act (21 U.S.C. 360oo(a) (3) and (a) (4)) also prohibit any manufacturer from failing or refusing 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. 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 USC 360pp). Persons who violate section 538 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 (21 CFR 17.2). In cases where a foreign manufacturer fails to respond, penalties may be imposed upon importers.
You are required, under 21 CFR 1003.11(b), to immediately provide a written response to FDA with the number of referenced products that 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. We request that you provide such a response no later than 15 days after receipt of this letter to one of the options listed below.
1. Refutation - Under 21 CFR 1003.11 (a) (3), you may submit your views and evidence to establish that the alleged failures to comply do not exist.
2. Exemption Request - Under 21 CFR 1003.30(a), you may request an exemption from user and dealer/distributor notification requirements in 21 CFR 1003.10(b). You must respond within 15 days from receipt of this letter to apply for such an exemption (21 CFR 1003.30(a)). If exempted from such notification, you are not required to correct the violative products (21 CFR 1004.1(a)). Under 21 CFR 1003.30(b), your request must include the information required by 21 CFR 1003.20 and set forth in detail the grounds upon which such exemption is sought.
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) for approval showing how you will fulfill your obligation under 21 CFR 1004.1 to repair, replace, or refund the cost of the
violative products (21 CFR 1004.1(b)).
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. Such a plan must expeditiously correct the noncompliance(s) and must be approved by FDA as set out in 21 CFR 1004.6.
If you request additional time to prepare your refutation, notification, CAP, or evidence to support a requested exemption, you should 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 1003.10(b) in the manner specified in 21 CFR 1003.21 (21 CFR 1003.11(c)). Therefore, you are encouraged to immediately begin your preparation of accurate user location lists.
You are responsible for complying with all applicable statutory and regulatory requirements before these products are introduced, or delivered for introduction into commerce, or imported into the United States. Such requirements include the completion of any production changes required under 21 CFR 1004.1 under a plan approved by FDA to assure compliance of future units, and the submission of any required reports. 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. You are also requested to send a copy of your response to: Director, Compliance Branch, Atlanta District Office, Food and Drug Administration, 60 Eight St. NE, Atlanta, GA 30309. 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
Office of Communication, Education,
and Radiation Programs
Center for Devices and Radiological Health