Inspections, Compliance, Enforcement, and Criminal Investigations
Hontech Foundation for Medical Technology 10-Jun-08
Department of Health and Human Services
Public Health Service
New England District
VIA CERTIFIED MAIL
June 10, 2008
Mr. Huan-Chen Li, Ph.D., M.D.
Hontech Foundation for Medical Technology
4 Swedes Crossing
Westford, MA 01886
Dear Mr. Li:
During an inspection of your firm located in Westford, Massachusetts on January 9 through March 3, 2008, and May 8, 2008 an investigator from the United States Food and Drug Administration (FDA) determined that your firm is an importer, repackager, and initial distributor for the medical device: the Electronic Itch Stopper.Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.
This inspection revealed that the Electronic Itch Stopper is adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 351 (h)), in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations, (C.F.R.), Part 820. These violations include, but are not limited to, the following:
1. Failure to establish quality system procedures and instructions, as required by 21 C.F.R. § 820.20(e).
Specifically, there are no written quality procedures nor is your firm's management aware of the QS regulation.
2 Failure to establish, maintain, and document procedures for implementing corrective and preventive actions, as required by 21 C.F.R. § 820.100.
Specifically, your firm does not have any written corrective or preventive action procedures.
3. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints, as required by 21 C.F.R. § 820.198(a).
Specifically, your firm does not have any written complaint procedures.
4. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 C.F.R. § 820.50(a).
Specifically, your firm does not have written specifications for devices purchased from suppliers, nor does it have documentation demonstrating supplier evaluations and oversight.
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 FDA 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. Additionally, premarket approval applications for Class III devices to which the QS 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 device has been corrected.
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: Maren Forsyth, Food & Drug Administration, One Montvale Avenue, Fourth Floor, Stoneham, Massachusetts 02180. If you have any questions about the content of this letter please contact Ms. Forsyth at (781) 596-7769.
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. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483, issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.
Michael R. Kravchuk
Acting District Director
New England District
The inspection also revealed that your firm was an importer, repackager, and initial distributor for the medical device Acne Machine, however, you have represented to FDA that you have ceased selling this product.