Inspections, Compliance, Enforcement, and Criminal Investigations
Electro-Therapeutic Devices, Inc. FDA Response Letter
|
Public Health Service Food and Drug Administration |
| 2094 Corporate Blvd. Rockville, MD 20850 |
Department of Health and Human Services
December 10, 2004
FEDERAL EXPRESS
Mr. K.C. Choong, Executive Officer
Electro-Therapeutic Devices, Inc.
570 Hood Road, Suite 14
Markham, Ontario
Canada L3R 4G7
Dear Mr. Choong:
This is in response to your letter dated October 8, 2004, which we did not receive until November 16, wherein you provided some additional documentation that we discussed with you at our meeting of October 28, 2004, in Rockville, Maryland.
We have reviewed your information and have decided to close out the responses you have provided. The adequacy of the changes to your procedures and documentation will be verified at the next routinely scheduled inspection at your facility. Also, we are removing your ACCU-O-MATIC SP Series Transcutaneous Nerve Stimulator devices and ADDIQUIP Acupuncture Needles from import detention. You may resume distribution of these products.
If you have any questions, you may contact me by telephone at 240-276-0120, or by email at maf@cdrh.fda.gov.
Sincerely yours,
Mary Ann Fitzgerald
Consumer Safety Officer
Cardiovascular and Neurological
Devices Branch
Division of Enforcement B
Office of Compliance
Center for Devices and Radiological Health