CLOSEOUT LETTER
Les Laboratoires Blanchard Jun 24, 2014
Les Laboratoires Blanchard - Close Out Letter 6/24/14
- Les Laboratoires Blanchard
| Public Health Service |
| Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 |
Department of Health and Human Services
JUN 24, 2014
Mr. Jean Blanchard
Co-owner and President
Les Laboratoires Blanchard
1552 King Ouest, Suite 200
Sherbrooke, Quebec J1J2C3
Canada
Dear Mr. Blanchard:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, CMS #249294, dated December 23, 2011. Based on our evaluation, it appears that your firm has 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/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health
cc:
Mr. Pierre L. Blanchard, Co-Owner
Les Laboratoires Blanchard
1552 King Ouest, Suite 200
Sherbrooke. Quebec J1J2C3
Canada