• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Beckman Coulter, Inc. - Close Out Letter 1/21/14

  

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

 
 Food and Drug Administration
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751

Telephone: 407-475-4700
             FAX: 407-475-4770

 

January 21, 2014


Cynthia L. Collins
Group Vice President Cellular Analysis Business
Beckman Coulter, Inc.
11800 SW 147th Avenue
Miami, FL 33196


Dear Ms. Collins:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [FLA-12-01, dated November 1, 2011]. Based on our evaluation, it appears that you have addressed the violation(s) 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/

Kathleen M. Sinninger
Acting Director, Florida District