Inspections, Compliance, Enforcement, and Criminal Investigations
Softlens Technology 27-Sep-06
Department of Health and Human Services
Public Health Service
Atlanta District Office
September 27, 2006
VIA FEDERAL EXPRESS
393 N. Sessions Street, NW
Marietta, GA 30060
Dear Mr. Kim:
During an investigation of [redacted] located in Atlanta, Georgia on May 5-12, 2006, investigators from e United States Food and Drug Administration (FDA) determined that your firm distributes piano (non-corrective or zero-powered) tinted contact lenses. This investigation determined that your firm distributes a variety of plano lens products under several brand names, such as and [redacted] and [redacted]. Softlens is the initial importer for these lenses which are manufactured by [redacted] in [redacted]. [redacted] was identified as the primary distributor for Softlens Technology of these piano lens products. FDA has determined that these lenses are being sold to retail establishments such as flea markets, gas stations, beauty shops, clothing stores, and beauty supply stores without requiring any evidence of proper fitting or other eye care professional involvement.
As you may be aware, Public Law 109-96 was enacted into law on November 9, 2005, deeming all contact lenses to be devices under section 201(h) of a United States law, the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(h)]. The Act requires that manufacturers of medical devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that newly introduced devices are safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.
The lenses distributed by your firm have been cleared by FDA for prescription use only. Therefore, because these devices are being sold without the order of a licensed practitioner, they are misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1) in that their labeling fails to bear adequate directions for use as required by 21 C.F.R. § 801.5 and the devices do not meet the requirements for an exemption from section 502(f)(1) under 21 C.F.R. § 801.109 and 801.110.
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 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 occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please 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 Philip S. Campbell, Compliance Officer, at the address noted in the letterhead. You may contact Mr. Campbell at (404) 253-1280 if you wish to set up a meeting at the district office to further discuss these issues.
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.
Mary H. Woleske
Atlanta District Office