Inspections, Compliance, Enforcement, and Criminal Investigations
Luv N' Care Ltd 9/11/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|4New Orleans District
404 BNA Drive
Building 200 - Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
September 11, 2009
WARNING LETTER NO. 2009-NOL-20
DELIVERY SIGNATURE REQUESTED
Mr. Joseph H. Hakim, President
Luv N' Care, Ltd.
3030 Aurora Avenue, 2nd Floor
Monroe, Louisiana 71201-7295
Dear Mr. Hakim:
On May 29,2009, a U.S. Food and Drug Administration (FDA) investigator visited your facility located in Monroe, Louisiana, as part of an investigation of your products and determined your firm is an initial importer and specification developer of Nuby™ gel-filled teethers. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 United State Code (USC) 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.
This investigation revealed these products are adulterated with the meaning of Section 501(a)(l) [21 USC 351(a)(l)] because they consist in whole or in part of a filthy, putrid, or decomposed substance. During the investigation, samples of your Nuby™ IcyBite™ teether and Nuby™ Fun Pal™ teether were collected and submitted to FDA's Southeast Regional Laboratory for microbial analysis. The Nuby™ IcyBite™ teether was determined to contain Bacillus circulans and your Nuby™ Fun Pal™ teether was determined to contain Bacillus subtilis.
Our investigation revealed the gel filled teethers are adulterated under Section 501(f)(l)(B), 21 USC 351 (f)(l)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to Section 515(a) of the Act, [21 USC 360e(a)], or an approved application for an investigational device exemption (IDE) under Section 520(g) of the Act, [21 USC 360j(g)]. The device is misbranded under Section 502(0) the Act, [21 USC 352(0)], because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by Section 510(k) of the Act, [21 USC 360(k)]. For a device requiring PMA, the notification required by Section 510(k) of the Act, [21 USC 360(k)], is deemed satisfied when a PMA is pending before the agency. The 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. FDA will evaluate the information you submit and decide whether your product may be legally marketed
Finally, the investigation revealed your firm lacks registration and device listing. Therefore, devices manufactured or distributed by you are misbranded under Section 502(0) of the Act, [21 USC 352(0)], because the device was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under Section 510, 21 USC 360; was not included in a list required by Section 510(j), 21 USC 360(j); and a notice or other information respecting the device was not provided to the FDA, as required by Section 510(k), 21 USC 360(k).
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. Federal agencies are advised of the issuance of all warning letters about devices so they may take this information into account when considering the award of contracts. Additionally, PMA applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
You must notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from recurring. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: Mark W. Rivero, Compliance Officer, at the address above. If you have any questions about the content of this letter, please contact Mr. Rivero at (504) 219-8818, extension 103.
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.
Patricia K. Schafer
Acting District Director
New Orleans District