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. Instituto Bioclon, S.A. de C.V. - Close Out Letter 8/4/15
  1. Warning Letters

CLOSEOUT LETTER

Instituto Bioclon, S.A. de C.V.


Instituto Bioclon, S.A. de C.V.

  

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

 
 Food and Drug Administration
Silver Spring MD 20993

AUG 4 2015

Guillermo Funes
Chief Executive Officer
Silanes / Instituto Bioclon S.A. de C.V.
Amores 1304, Col. Del Valle
México D. F., C. P. 03100

Dear Mr. Funes:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [CBER-14-02, April 16, 2014]. 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/

Mary A. Malarkey
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research


cc: Michelle Taylor
     Vice President, Regulatory Affairs & Quality Assurance
     Rare Disease Therapeutics, Inc.
     9550 Cuyamaca Street, Suite 203
     Santee, CA 92071

     Milton Ellis
     President
     Rare Disease Therapeutics, Inc.
     1101 Kermit Drive, Ste 608
     Nashville, TN 3 721 7