Inspections, Compliance, Enforcement, and Criminal Investigations
Wheaton Beauty Supply 27-Aug-07
Department of Health and Human Services
Public Health Service
August 27, 2007
RETURN RECEIPT REQUESTED
Jae Soo Lee, Owner
Wheaton Beauty Supply
11160 Veirs Mill Road
Wheaton, Maryland 20902
Dear Mr. Lee:
We are writing to you because on May 30, 2007, an investigator from the Food and Drug Administration (FDA) purchased plano (non-corrective) tinted contact lenses from your firm in Wheaton, Maryland. After purchasing these lenses, the investigator conducted an inspection of your facility.
Based upon this purchase and inspection, the investigator determined that your firm markets plano lenses directly to consumers without requiring any evidence of proper fitting or other eye care professional involvement. FDA has determined that these lenses are marketed without labeling describing the risks associated with the wearing of such lenses.
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. Prescription devices are exempt from the Act's requirement that they bear adequate directions for use (section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1); 21 C.F.R. § 801.5), if, among other things, they are to be sold only to a licensed practitioner or on the prescription or other order of the practitioner for use in the course of his or her professional practice, 21 CFR 801.109(a). Because they are being sold without a prescription, the plano contact lenses sold by your firm are misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1).
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly, correct the violation(s) may result in regulatory action by the Food and Drug Administration without. These actions include, but are not limited to, seizure, injunction, and/or civil money" further notice 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.
We request that you notify this office in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct the noted violations(s). Your response should address the comments listed above and include examples of documentation showing that corrections have been achieved. If corrective action can not be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed.
Your reply should be directed to Randy F. Pack, Compliance Officer, Food and Drug Administration, Baltimore District Office, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have any questions, please do not hesitate to contact Mr. Randy F. Pack at (410) 779-5454, extension 417.
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 the FDA. You should investigate and determine the causes of violation(s), and take prompt actions to correct the violation(s) and bring your product into compliance.