U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Quality Electrodynamics LLC - Close Out Letter 10/15/16
  1. Compliance Actions and Activities

CLOSEOUT LETTER

Quality Electrodynamics LLC 15/10/2016

Quality Electrodynamics LLC - Close Out Letter 10/15/16


Quality Electrodynamics LLC

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2771 

October 12, 2016
 

Hiroyuki Fujita, PhD
President and CEO
Quality Electrodynamics, LLC
6655 Beta Drive, Suite 100
Mayfield Village, OH 44143-2378
 

Dear Dr. Fujita:
 

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CIN-15-455248-15, dated April 10, 2015. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
 

Sincerely,
/S/
Gina M. Brackett
Compliance Officer
Cincinnati District