| Public Health Service |
555 Winderley PI., Ste. 200 |
Departmentof Health and Human ServicesVIA CERTIFIED MAIL
WARNING LETTER
FLA-03-10
November 18, 2002
William Donaldson, President
Youth Light 2010, Inc,.
150 E. Sample Road
Pompano Beach, Florida 33064
Dear Mr. Donaldson
We are writing to you because during an inspection of your establishment located in Pompano Beach, Florida on July 10-16, 2002, Food and Drug Administration (FDA) investigators Michelle S. Dunaway and Prince Brown determined that your establishment is a specification developer and distributor of the Youth Light 2010 Intense Pulse Light System. As a specification developer, you are considered to be a manufacturer in accordance with Title 21, Code of Federal Regulations (CFR), Section 807.20(a)(1).
Under a United States law, the Federal Food, Drug, and Cosmetic Act (the Act), the Youth Light 2010 is considered to be a medical device because it is intended to be used to diagnose or treat a medical condition or to affect the structure or function of the body. The law requires that manufacturers of medical devices obtain marketing clearance for their products from the FDA before they may offer them for sale. This helps protect the public heath by ensuring that newly introduced medical devices are safe and effective or substantially equivalent to other devices already legally marketed in this country.
The inspection determined that you promote and distribute the Youth Light 2010 device for structure/function claims including the treatment of wrinkles, lines and folds, age spots and sun damage, coarse skin and large pores, and for the promotion of collagen production.
Our records do not show that you obtained marketing clearance before you began offering your product for safe. The kind of information you need to submit in order to obtain this clearance is described on FDA's medical device website at .http://www.fda.gov/cdrh/devadvice. FDA will evaluate this information and decide whether your product maybe legally marketed
Be cause you do not have marketing clearance from the FDA, marketing your product is a violation of the law. In legal terms, the product is adulterated under section 501(f)(1)(B) and misbranded under section 502(o) of the Act. Your product is misbranded under the Act because you did not submit a section 510(k) premarket notification that shows your device is substantially equivalent to other devices that are legally marketed.
Until you submit a section 510(k) premarket notification and FDA reviews it and notifies you that you may market your device, your product is also adulterated under the Act because the law requires, and you do not have, an approved premarket approval application that shows your device is safe and effective.
The above-stated inspection revealed that the device is adulterated under Section 501(h) of the Act, in that the methods used in, or the facilities or controls used for manufacturing, packing, storage, or installation are not in conformance with the current Good Manufacturing Practice (CGMP) requirements of the Quality System Regulation.
1. Your firm's management with executive responsibility failed to establish its policy and objectives for, and commitment to, quality as required by 21 CFR 820.20(a),(c), and (e). For example, you do not have any written procedures documenting any of your firm's management activities and no quality audits or management reviews have been conducted (FDA 483, Item #11, 2, and 13).
2. Your firm failed to establish procedures for quality audits and to conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system as required by 21 CFR 820.22. For example, no quality audits have been conducted and none are scheduled to assure the quality system is effective (FDA 483, Item #12).
3. Your firm failed to establish and maintain procedures to control the design of the device in order to ensure that specified requirements are met as required by 21 CFR 820.30 (f),(g), and (j). For example, no design verification confirmed that the design outputs meet design input requirements, design validation did not ensure that devices conform to defined user/patient needs and intended uses, and a design history file was not established or maintained.(FDA 483, Item #s 8,9, and 10).
4. Your firm failed to maintain records of complaint investigations by a formally designated unit as required by 21 CFR 820.198(e). Your firm received several complaints that were not documented (FDA 483, Item #11).
5. Your firm failed to establish and maintain device master records (DMRs)which include specifications (appropriate drawings composition, and/or component specifications), for maintenance and service of equipment, for production or process operations, for quality assurance, for packaging and labeling operations, and the DMR does not include or refer to the location of these records as required by 21 CFR 820.181 (a), (b), (c), and (d). For example, there are no production and process procedures/specifications, no quality assurance procedures/specifications, no packaging and labeling procedures, and there was no reference as to where these records are maintained (FDA 483, Item #s 3, 4; 5, 6, and 7).
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. Mr. William Chappie promised to respond in writing documenting corrective actions taken covering the observed deviations listed on the Inspectional Observations (FDA 483) and verifying that distribution of the device had been discontinued. As of this date, no response has been received.
You should know that this serious violation of the law may result in FDA taking regulatory action without further notice to you. These actions include, but are not limited to, seizing your product inventory, obtaining a court injunction against further marketing of the product, or assessing civil money penalties. Also, Federal agencies are informed about the Warning Letters we issue, such as this one, so that they may consider this information when awarding government contracts. Additionally, no requests for Certificates for Products for Export will be approved until the violations related to the subject devices have been corrected.
It is necessary to take action on this matter now. Please let this office know what steps you have taken to correct the problem within fifteen (15) working days from the date you received this letter, including: (1) the time frames within which the corrections will be completed, (2) any documentation indicating the corrections have been achieved, and (3) an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure that similar violations will not recur. Please adviseyour intentions to cease distribute. If you need more time, let us know why and when you expect to complete your correction. Please direct your response to Mr. Timothy J. Couzins, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751, (407) 75-4728.
Sincerely,
/s/
Emma Singleton
Director, Florida District
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