Inspections, Compliance, Enforcement, and Criminal Investigations
Subcon Manufacturing Corporation 15-Feb-05
Department of Health and Human Services
Public Health Service
February 15, 2005
RETURN RECEIPT REQUESTED
Mr. Charles T. Walneck, President
Subcon Manufacturing Corporation
201 Berg Street
Algonquin, Illinois 60102
Dear Mr. Walneck:
During the inspection of your firm on August 24 and 26, 2004, a Food and Drug Administration (FDA) investigator determined that your firm is the contract manufacturer of the "Revitalight Skin Care System" product. The product "Revitalight Skin Care System" is considered to be a medical device as defined by 201(h) of the Federal Food, Drug, and Cosmetic Act (Act).
Under the Federal Food, Drug, and Cosmetic Act, this product is considered to be a medical device because it is intended for use in the diagnosis or treatment of a medical condition or intended 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 health by ensuring that newly introduced medical devices are safe and effective or substantially equivalent to other devices already legally marketed in this country.
Because neither you nor the specification developer, Skincare Technology, has marketing approval or clearance from the FDA for the Revitalight Skin Care System, marketing this product is a violation of the law. In legal terms, this product is adulterated under Section 501(f)(1)(B) of the Act. Until the agency has reviewed a 510(k) and determined that the Revitalight SkinCare System is substantially equivalent to a legally marketed device, this product is 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. For a product requiring premarket approval, the notification required by Section 510(k) of the Act is deemed to be satisfied when a premarket approval application (PMA) is pending before the agency [21 CFR 807.81(b)].
The above referenced inspection revealed that this device is adulterated under Section 501(h) of the Act, in that the methods used in, or the facilities or controls used for, its manufacture, packing, storage, or installation are not in conformance with the current Good Manufacturing Practice (cGMP) requirements for medical devices which are set forth in the Quality System regulation, as specified in 21 CFR Part 820. Significant deviations include, but are not limited to, the following;
Failure to conduct quality 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 audits of the quality assurance program have been performed.
Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).
Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a).
Failure to establish and maintain procedures to ensure that device history records (DHR) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record (DMR) and the requirement of this part, as required by 21 CFR 820.184. For example, there are no DHR's for the Revitalight Skin Care System.
Failure to have procedures established for management with executive responsibility to review the suitability and effectiveness of the quality system to ensure that the quality system satisfies the requirements of this part, as required by 21 CFR 820.20(6).
Failure to establish and maintain procedure for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a).
Failure to establish and maintain procedures to ensure that all purchased or other wise received product and services conform to specified requirements, as required by 21 CFR 820.50.
Failure to establish and maintain procedures that define the responsibility for review and authority for the disposition of nonconforming product, as required by 21 CFR 820.90(b),
Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented, as required by 21 CFR 820.25(b).
Failure to establish procedures to control all documents that are required by this part, as required by 21 CFR 820.40.
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. The specific violations noted in this letter and on the FDA 483 issued at the close of the inspection maybe symptomatic of serious underlying problems in your firm's manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by the FDA. You also must promptly initiate permanent corrective and preventative action on your quality system.
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. Additionally, no premarket submissions for Class III devices for which the Quality System Regulation deficiencies are reasonably related will be cleared or approved until the violations have been corrected. Also no requests for certificates to foreign governments will be approved until the violations related to the subject devices have been corrected.
You should know that these serious violations 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.
We acknowledge receipt of your response letters dated December 20, 2004 and October 5, 2004, and materials related to proposed changes to your quality system. We cannot consider the anticipated changes to your quality system as satisfactory on the basis of the materials submitted. We also acknowledge your response in a letter dated September 17, 2004, in which your attorney stated that you would be amenable to revising your claims in your promotional materials, leaving only claims that are unquestionably cosmetic. In your response to this letter, please provide revised labeling and promotional materials that eliminate unclear medical device claims.
It is necessary to take action on these matters now. Please let this office know in writing what steps you have taken to correct these problems within 15 working days from the date you received this letter. We also ask that you explain how you plan to prevent this from happening again. If you need more time, let us know why and when you expect to complete your correction.
Your response should be addressed to Matthew Sienko, Compliance Officer, at the above address.
Scott J. MacIntire