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. bioMerieux, Inc. - 08/30/2017
  1. Warning Letters


bioMerieux, Inc.

bioMerieux, Inc.

United States

Issuing Office:

United States



Black HHS-Blue FDA Logo


Office of Medical Device and Radiological Health Operations (OMDRHO)
Division 2 Central
555 Winderley Pl # 200
Maitland, FL 32751
Telephone: (407) 475-4700 



August 30, 2017

Kenneth W. Allen, Quality Director
bioMerieux, Inc.
100 Rodolphe Street
Durham, NC 27712

Dear Dr. Allen:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [12-ATL-17 dated August 23, 2012]. 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.


Blake Bevill, M.S.
Acting Program Division Director
Office of Medical Device and Radiological Health
Division 2 – Central

Back to Top