| Public Health Service Food and Drug Administration |
San Francisco District |
Department of Health and Human ServicesWARNING LETTER
CMS# 167292
VIA UNITED PARCEL SERVICE
July 5, 2011
Mr. David P. Mayer
President/CEO
Mayer Laboratories, Inc.
1950 Addison Street, Suite 101
Berkeley, California 94704
Dear Mr. Mayer:
During an inspection of your firm located in Berkeley, California on January 24, 2011 through February 7, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is the specification developer and the distributor of the Aqua Lube Personal Lubricant and the Kimono MicroThin Latex Condom with Aqua Lube. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 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 function of the body.
On June 18, 2009, the Agency acknowledged the receipt of your firm’s 510(k) application for the Aqua Lube and assigned it K091801. In this submission, you indicate that this device is designed to provide lubrication to supplement the body’s own natural fluids or additional moisture in order to reduce friction during sexual activity. Additionally, you indicate that the product may be used as an accessory to condoms. We reviewed your application and requested additional information in order to complete our review. You responded to our concerns in a letter dated December 29, 2009. Upon further review, we informed you that the application remains deficient because it lacked biocompatibility data for its intended use and we had concerns regarding the product labeling. These deficiencies were detailed in our letter to you dated February 5, 2010. You requested additional time to address our concerns and your request was granted. However, you did not submit the requested information and, in our August 13, 2010, letter, we informed you that the extension of time had expired and the submission was considered withdrawn. Our letter specifically informed you that “YOU MAY NOT PLACE THIS DEVICE INTO COMMERCIAL DISTRIBUTION UNTIL YOU RECEIVE A LETTER FROM THE FDA ALLOWING YOU TO DO SO.”
Although you were informed by the Agency that you may not distribute the Aqua Lube device, our inspection revealed that you have been offering and continue to offer this device for commercial distribution since October 2010.
Furthermore, our inspection revealed that you are a specification developer and distributor of Kimono MicroThin Latex Condom with the water-based Aqua Lube lubrication. You have not received clearance or approval for the Kimono MicroThin Latex Condom with Aqua lube lubrication. Nor have you received clearance or approval for any condom with the Aqua Lube lubrication. The Kimono MicroThin Latex Condom was cleared (K946374) with a silicone oil lubricant. Changing the lubricant is a significant change or modification in device materials that impacts condom biocompatibility and physical properties, and, as such, requires the submission of a new 510(k) per [21 CFR 807.81(a)(3)(i)].
As described above, your devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do 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 (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The devices are also misbranded under section 502(o) the Act, 21 U.S.C. 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 U.S.C. 360(k) and 21 CFR 807.100(a). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)] The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
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 the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all 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 15 business days from the date you receive this letter of the specific steps you have taken to correct the noted violations, as well as an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions you have taken. If your planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of these activities. If corrections and/or corrective actions cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed. Your response should be comprehensive and address all violations included in this Warning Letter.
Additionally in your response, please indicate what you plan to do with the adulterated and misbranded devices you have already distributed.
Please direct your response to:
Darlene B. Almogela
Director of Compliance
1431 Harbor Bay Parkway
Alameda, California 94052
Refer to the unique CMS case # 167292 when replying. If you have questions about the content of this letter, please contact Mr. Lawton W. Lum, Compliance Officer at (510) 337-6792.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Sincerely yours,
/s/
Barbara J. Cassens
District Director
San Francisco District
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