Inspections, Compliance, Enforcement, and Criminal Investigations
J & B Products, Ltd. 01-Dec-03
Department of Health and Human Services
Public Health Service
Baltimore District Office
December 1, 2003
RETURN RECEIPT REQUESTED
Mr. Joseph C. Bommarito, President
J & B Products, Ltd.
dba International Tanning Equipment
2201 S. Michigan Ave.
Saginaw, MI 48602-1275
Dear Mr. Bommarito:
During an inspection of an International Tanning Equipment tanning bed, model #SW-24M51 located at Un-Sun Tanning Salon, 523E. Main Street, Reisterstown, MD 21136 on September 9, 2003, non- compliances with the Federal Performance Standards for Sunlamp Products (21 CFR 1040.20). were noted. Specifically, the following deviations were observed:
Failure to meet the label requirements promulgated in 21 CFR § 1040.20(d) in that:
The warning statement required by 21 CFR § 1040.20(d)(1)(i) is not permanently affixed so that it is readily accessible to view as required by 21 CFR §1040.20(d)(3)(ii).
The label designating the ultraviolet lamp type to be used in the product, which is required by 21 CFR § 1040.20(d)(1)(vi), is not permanently affixed so that it is readily accessible to view as required by 21 CFR §1040.20(d)(3)(ii).
A recommended exposure schedule including duration and spacing of sequential exposure and maximum exposure times in minutes, which is required by 21 CFR §1040.20(d)(1)(iv), is not permanently affixed so that it is readily accessible to view as required by 21 CFR §1040.20(d)(3)(ii).
In addition, non-compliances with the Federal Performance Standards for Electronic Products were noted. Specifically, the following deviations were observed:
Failure to meet the certification requirements promulgated in 21 CFR 1010.2 in that a certification in the form of a label or tag is not permanently affixed to or inscribed on the product so as to be legible and readily accessible to view when the product is fully assembled.
Failure to provide the place, month and year of manufacture as required by 21 CPR §1010.3(a)(2).
Section 538(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA), Chapter V, Subchapter C (formerly the Radiation Control for Health and Safety Act of 1968) prohibits any manufacturer from certifying or introducing into commerce sunlamp products which do not comply with the standard. This section also prohibits any manufacturer from failure to establish and maintain required records or to submit required reports. Failure to respond to this letter may constitute a violation of sections 538(a)(2) and 538(a)(4) of the FFDCA.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in the Food and Drug Administration (FDA) initiating regulatory action without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties.
We request that you respond in writing within 15 days of receipt of this letter with one of the options listed below. In your response you should 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 non-compliances do not exist.
2. Exemption Request -You may request an exemption from the requirements of user and dealer/distributor notification and from the 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 non-compliance nor request an exemption, then you should: (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. Please note 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 CPR 1003.11(c) and 1003.21. Therefore, you are encouraged to immediately begin your preparation of accurate user location lists.
When you have completed all production changes necessary to assure compliance of future units, and have submitted to the Center for Devices and Radiological Health (with a copy to the District Office identified above) a supplement to your initial report describing these changes and any other information required to assure that your products comply with the performance standard, you may then resume introduction of the referenced sunlamp products into commerce.
If further information is required, please contact Steven B. Barber, Compliance Officer at 410-779-5134.
Acting District Direct